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Scholars in Solitude
Recently, six faculty colleagues and I were discussing socialization of students in distance-learning programs. Each of us shared concerns that had been voiced by students regarding the periods of isolation they frequently feel while studying or completing course assignments. The common theme was expressed as “not feeling connected” and “no real camaraderie” with fellow students. One of us also raised the issue of internal conflict; a student had described herself as enjoying the freedom to listen to lectures on her own schedule and not be obligated to attend class on a specific day at a specific time but simultaneously missing seeing her classmates on a weekly basis.
For the most part, my colleagues and I were all “bricks and mortar” students, tied to required attendance during scheduled classes. We collectively agreed that this was frequently a bother, but we recognized the advantage of being able to sit together before or after class to discuss assignments, bring clarity to confusion, or simply commiserate on the difficulties of balancing family, school, and work obligations. In my own doctoral studies, week-to-week support and encouragement kept us a close-knit group, seeing us through to completed dissertations.
As our conversation continued, we began to lament our own lack of connectedness, not to our students (we communicate with them at least, if not more than, once a week) but to our faculty colleagues. Our consensus was that the focus on student-to-faculty contact left faculty-to-faculty contact seemingly an afterthought—or not a thought at all. I consider myself lucky that most of “my faculty” were friends or professional colleagues prior to our academic postings. Thus, we had established relationships outside our faculty roles.
But this whole idea of the socialization of faculty in distance education got me wondering: Are there criteria or guidelines for communication among faculty? I don’t mean the required staff meetings; I mean something similar to the requirements for type, and frequency, of interactions with the students, which are set forth by credentialing entities. I wondered what I could find in the literature or educational texts about faculty “connectedness.” And so my search began.
Continue for where my search began >>
I started with Keating’s text,1 the table of contents of which listed a chapter on Distance Education. Hmm, I thought, there must be something there. Several sections were enlightening and could very easily provide guidance for faculty-student interactions, but not so much for faculty to faculty. Granted, the basis for the text is curriculum development, so I am not denigrating the work; I just hoped a chapter on program development would include something on developing faculty networks.
As my search continued, I found the Online Journal of Distance Learning Administration. Notable was research presented by Bower,2 who described findings of an American Faculty Poll conducted in 2000 noting that “direct engagement with the students is one of the most important factors” in an educator’s decision to pursue an academic career.3 In this poll, a flexible work schedule was viewed as very important by 60% of those surveyed; those of us who are engaged in distance education have the most control (I would submit) over our schedules. But there was no evidence that faculty who taught online were represented in that survey—and no discussion of faculty-to-faculty connections.
Despite repeated searches, I found a paucity of research regarding socialization (or lack thereof) among faculty teaching in the online environment. In her dissertation, Heilman4 addressed perceptions of satisfaction with online teaching. One element she researched was faculty/peer relationships. Her participants noted that “networking and sharing with other online faculty members who work in another location” enhanced their satisfaction, but several noted that “lack of interactions or feeling isolated from their peers” diminished their satisfaction with online teaching. In reading their comments, I formed the impression that the interactions were initiated by the individual faculty, rather than facilitated by the institution.
Recently, I have seen blog posts addressing the issue of transforming clinicians to academics. There is a universal understanding that being an expert clinician does not necessarily mean you are a proficient educator. Moreover, transitioning from a face-to-face system to an online environment can be intimidating. Faculty, especially those new to the role, may need additional support.
Having an internal social network for online faculty is a means to achieving a supportive community and building a mentoring culture within an institution. A faculty member who has a sense of connectedness to other faculty (onsite and online) is as important to the successful online environment as is the development of a sense of community for students. The community must serve to enhance learning and teaching for both groups.
There are several published guidelines for successful online teaching—that is, what faculty can do for students. I have taken those principles, modified them, and applied them as suggestions for improving the socialization of faculty. With recognition of those who devised them5,6 and acknowledgement of the poetic license applied, here they are:
• Encourage faculty-to-faculty contact outside mandatory meetings
• Encourage faculty collaboration beyond course/institutional requirements
• Provide for live, interactive events that are fun.
With the ever-increasing number of educational institutions providing online programs (now at about 89%7), it is imperative that we as faculty and program administrators include socialization as a component of faculty orientation and training. What better than a connected faculty to enhance student achievement?
When we’re on site, my faculty colleagues and I plan dinner together. During commencement week, laughter and camaraderie from “unofficial” social activities allow us to relax, celebrate another successful class, and form memories that we carry with us throughout the year. What about your institutions? Please share your ideas about “staying connected” to colleagues in a digital environment by writing to [email protected].
References
1. Keating SB. Curriculum Development and Evaluation in Nursing. Philadelphia, PA: Lippincott Williams and Wilkins; 2006.
2. Bower BL. Distance education: facing the faculty challenge. Online J Distance Learning Admin. 2001;4(2).
3. Sanderson A, Phua VC, Herda D. The American Faculty Poll. Chicago: National Opinion Research Center; 2000.
4. Heilman JG. Higher education faculty satisfaction with online teaching [dissertation]. 2007. http://hdl.handle.net/2152/3796. Accessed February 15, 2016.
5. Koeckeritz J, Malkiewicz J, Henderson A. The seven principles of good practice: applications for online education in nursing. Nurse Educ. 2002;27(6):283-287.
6. Chickering AW, Gamson ZF. Seven principles for good practice in undergraduate education. AAHE Bulletin. 1987;39(7):3-7.
7. Parker K, Lenhart A, Moore K. The Digital Revolution and Higher Education: College Presidents, Public Differ on Value of Online Learning. Washington, DC: Pew Research Center; 2011.
Recently, six faculty colleagues and I were discussing socialization of students in distance-learning programs. Each of us shared concerns that had been voiced by students regarding the periods of isolation they frequently feel while studying or completing course assignments. The common theme was expressed as “not feeling connected” and “no real camaraderie” with fellow students. One of us also raised the issue of internal conflict; a student had described herself as enjoying the freedom to listen to lectures on her own schedule and not be obligated to attend class on a specific day at a specific time but simultaneously missing seeing her classmates on a weekly basis.
For the most part, my colleagues and I were all “bricks and mortar” students, tied to required attendance during scheduled classes. We collectively agreed that this was frequently a bother, but we recognized the advantage of being able to sit together before or after class to discuss assignments, bring clarity to confusion, or simply commiserate on the difficulties of balancing family, school, and work obligations. In my own doctoral studies, week-to-week support and encouragement kept us a close-knit group, seeing us through to completed dissertations.
As our conversation continued, we began to lament our own lack of connectedness, not to our students (we communicate with them at least, if not more than, once a week) but to our faculty colleagues. Our consensus was that the focus on student-to-faculty contact left faculty-to-faculty contact seemingly an afterthought—or not a thought at all. I consider myself lucky that most of “my faculty” were friends or professional colleagues prior to our academic postings. Thus, we had established relationships outside our faculty roles.
But this whole idea of the socialization of faculty in distance education got me wondering: Are there criteria or guidelines for communication among faculty? I don’t mean the required staff meetings; I mean something similar to the requirements for type, and frequency, of interactions with the students, which are set forth by credentialing entities. I wondered what I could find in the literature or educational texts about faculty “connectedness.” And so my search began.
Continue for where my search began >>
I started with Keating’s text,1 the table of contents of which listed a chapter on Distance Education. Hmm, I thought, there must be something there. Several sections were enlightening and could very easily provide guidance for faculty-student interactions, but not so much for faculty to faculty. Granted, the basis for the text is curriculum development, so I am not denigrating the work; I just hoped a chapter on program development would include something on developing faculty networks.
As my search continued, I found the Online Journal of Distance Learning Administration. Notable was research presented by Bower,2 who described findings of an American Faculty Poll conducted in 2000 noting that “direct engagement with the students is one of the most important factors” in an educator’s decision to pursue an academic career.3 In this poll, a flexible work schedule was viewed as very important by 60% of those surveyed; those of us who are engaged in distance education have the most control (I would submit) over our schedules. But there was no evidence that faculty who taught online were represented in that survey—and no discussion of faculty-to-faculty connections.
Despite repeated searches, I found a paucity of research regarding socialization (or lack thereof) among faculty teaching in the online environment. In her dissertation, Heilman4 addressed perceptions of satisfaction with online teaching. One element she researched was faculty/peer relationships. Her participants noted that “networking and sharing with other online faculty members who work in another location” enhanced their satisfaction, but several noted that “lack of interactions or feeling isolated from their peers” diminished their satisfaction with online teaching. In reading their comments, I formed the impression that the interactions were initiated by the individual faculty, rather than facilitated by the institution.
Recently, I have seen blog posts addressing the issue of transforming clinicians to academics. There is a universal understanding that being an expert clinician does not necessarily mean you are a proficient educator. Moreover, transitioning from a face-to-face system to an online environment can be intimidating. Faculty, especially those new to the role, may need additional support.
Having an internal social network for online faculty is a means to achieving a supportive community and building a mentoring culture within an institution. A faculty member who has a sense of connectedness to other faculty (onsite and online) is as important to the successful online environment as is the development of a sense of community for students. The community must serve to enhance learning and teaching for both groups.
There are several published guidelines for successful online teaching—that is, what faculty can do for students. I have taken those principles, modified them, and applied them as suggestions for improving the socialization of faculty. With recognition of those who devised them5,6 and acknowledgement of the poetic license applied, here they are:
• Encourage faculty-to-faculty contact outside mandatory meetings
• Encourage faculty collaboration beyond course/institutional requirements
• Provide for live, interactive events that are fun.
With the ever-increasing number of educational institutions providing online programs (now at about 89%7), it is imperative that we as faculty and program administrators include socialization as a component of faculty orientation and training. What better than a connected faculty to enhance student achievement?
When we’re on site, my faculty colleagues and I plan dinner together. During commencement week, laughter and camaraderie from “unofficial” social activities allow us to relax, celebrate another successful class, and form memories that we carry with us throughout the year. What about your institutions? Please share your ideas about “staying connected” to colleagues in a digital environment by writing to [email protected].
References
1. Keating SB. Curriculum Development and Evaluation in Nursing. Philadelphia, PA: Lippincott Williams and Wilkins; 2006.
2. Bower BL. Distance education: facing the faculty challenge. Online J Distance Learning Admin. 2001;4(2).
3. Sanderson A, Phua VC, Herda D. The American Faculty Poll. Chicago: National Opinion Research Center; 2000.
4. Heilman JG. Higher education faculty satisfaction with online teaching [dissertation]. 2007. http://hdl.handle.net/2152/3796. Accessed February 15, 2016.
5. Koeckeritz J, Malkiewicz J, Henderson A. The seven principles of good practice: applications for online education in nursing. Nurse Educ. 2002;27(6):283-287.
6. Chickering AW, Gamson ZF. Seven principles for good practice in undergraduate education. AAHE Bulletin. 1987;39(7):3-7.
7. Parker K, Lenhart A, Moore K. The Digital Revolution and Higher Education: College Presidents, Public Differ on Value of Online Learning. Washington, DC: Pew Research Center; 2011.
Recently, six faculty colleagues and I were discussing socialization of students in distance-learning programs. Each of us shared concerns that had been voiced by students regarding the periods of isolation they frequently feel while studying or completing course assignments. The common theme was expressed as “not feeling connected” and “no real camaraderie” with fellow students. One of us also raised the issue of internal conflict; a student had described herself as enjoying the freedom to listen to lectures on her own schedule and not be obligated to attend class on a specific day at a specific time but simultaneously missing seeing her classmates on a weekly basis.
For the most part, my colleagues and I were all “bricks and mortar” students, tied to required attendance during scheduled classes. We collectively agreed that this was frequently a bother, but we recognized the advantage of being able to sit together before or after class to discuss assignments, bring clarity to confusion, or simply commiserate on the difficulties of balancing family, school, and work obligations. In my own doctoral studies, week-to-week support and encouragement kept us a close-knit group, seeing us through to completed dissertations.
As our conversation continued, we began to lament our own lack of connectedness, not to our students (we communicate with them at least, if not more than, once a week) but to our faculty colleagues. Our consensus was that the focus on student-to-faculty contact left faculty-to-faculty contact seemingly an afterthought—or not a thought at all. I consider myself lucky that most of “my faculty” were friends or professional colleagues prior to our academic postings. Thus, we had established relationships outside our faculty roles.
But this whole idea of the socialization of faculty in distance education got me wondering: Are there criteria or guidelines for communication among faculty? I don’t mean the required staff meetings; I mean something similar to the requirements for type, and frequency, of interactions with the students, which are set forth by credentialing entities. I wondered what I could find in the literature or educational texts about faculty “connectedness.” And so my search began.
Continue for where my search began >>
I started with Keating’s text,1 the table of contents of which listed a chapter on Distance Education. Hmm, I thought, there must be something there. Several sections were enlightening and could very easily provide guidance for faculty-student interactions, but not so much for faculty to faculty. Granted, the basis for the text is curriculum development, so I am not denigrating the work; I just hoped a chapter on program development would include something on developing faculty networks.
As my search continued, I found the Online Journal of Distance Learning Administration. Notable was research presented by Bower,2 who described findings of an American Faculty Poll conducted in 2000 noting that “direct engagement with the students is one of the most important factors” in an educator’s decision to pursue an academic career.3 In this poll, a flexible work schedule was viewed as very important by 60% of those surveyed; those of us who are engaged in distance education have the most control (I would submit) over our schedules. But there was no evidence that faculty who taught online were represented in that survey—and no discussion of faculty-to-faculty connections.
Despite repeated searches, I found a paucity of research regarding socialization (or lack thereof) among faculty teaching in the online environment. In her dissertation, Heilman4 addressed perceptions of satisfaction with online teaching. One element she researched was faculty/peer relationships. Her participants noted that “networking and sharing with other online faculty members who work in another location” enhanced their satisfaction, but several noted that “lack of interactions or feeling isolated from their peers” diminished their satisfaction with online teaching. In reading their comments, I formed the impression that the interactions were initiated by the individual faculty, rather than facilitated by the institution.
Recently, I have seen blog posts addressing the issue of transforming clinicians to academics. There is a universal understanding that being an expert clinician does not necessarily mean you are a proficient educator. Moreover, transitioning from a face-to-face system to an online environment can be intimidating. Faculty, especially those new to the role, may need additional support.
Having an internal social network for online faculty is a means to achieving a supportive community and building a mentoring culture within an institution. A faculty member who has a sense of connectedness to other faculty (onsite and online) is as important to the successful online environment as is the development of a sense of community for students. The community must serve to enhance learning and teaching for both groups.
There are several published guidelines for successful online teaching—that is, what faculty can do for students. I have taken those principles, modified them, and applied them as suggestions for improving the socialization of faculty. With recognition of those who devised them5,6 and acknowledgement of the poetic license applied, here they are:
• Encourage faculty-to-faculty contact outside mandatory meetings
• Encourage faculty collaboration beyond course/institutional requirements
• Provide for live, interactive events that are fun.
With the ever-increasing number of educational institutions providing online programs (now at about 89%7), it is imperative that we as faculty and program administrators include socialization as a component of faculty orientation and training. What better than a connected faculty to enhance student achievement?
When we’re on site, my faculty colleagues and I plan dinner together. During commencement week, laughter and camaraderie from “unofficial” social activities allow us to relax, celebrate another successful class, and form memories that we carry with us throughout the year. What about your institutions? Please share your ideas about “staying connected” to colleagues in a digital environment by writing to [email protected].
References
1. Keating SB. Curriculum Development and Evaluation in Nursing. Philadelphia, PA: Lippincott Williams and Wilkins; 2006.
2. Bower BL. Distance education: facing the faculty challenge. Online J Distance Learning Admin. 2001;4(2).
3. Sanderson A, Phua VC, Herda D. The American Faculty Poll. Chicago: National Opinion Research Center; 2000.
4. Heilman JG. Higher education faculty satisfaction with online teaching [dissertation]. 2007. http://hdl.handle.net/2152/3796. Accessed February 15, 2016.
5. Koeckeritz J, Malkiewicz J, Henderson A. The seven principles of good practice: applications for online education in nursing. Nurse Educ. 2002;27(6):283-287.
6. Chickering AW, Gamson ZF. Seven principles for good practice in undergraduate education. AAHE Bulletin. 1987;39(7):3-7.
7. Parker K, Lenhart A, Moore K. The Digital Revolution and Higher Education: College Presidents, Public Differ on Value of Online Learning. Washington, DC: Pew Research Center; 2011.
Working with scribes—the good, the surprising
The clerical work involved in managing the electronic medical record (EMR) is clearly not at the top of the skill set for physicians, yet many office-based clinicians find themselves bogged down in this work with no easy way out.
However, practices that are adopting team-based care—where each team member works at the top of his or her skill set—are finding a solution in the form of scribing, or team documentation. This approach can ease that burden and perhaps even help to curb physician burnout in the process. But many questions still surround this approach, notably: What do we know about the quality of this documentation?
Research conducted by Misra-Hebert et al reported on in this issue provides some insight—and reason for optimism. (See “Medical scribes: How do their notes stack up?”) Their study found that scribes’ outpatient notes stack up quite well when compared to those of physicians. And having worked with this approach to documentation, I can attest to its benefits, as well.
Two approaches, one goal. There are 2 different ways that physicians can get help with documentation. One involves the use of trained scribes, who come from a variety of backgrounds and are charged with writing down, or scribing, what the physician says. The other involves training staff, usually certified medical assistants (CMAs) or licensed practical nurses (LPNs), to take on a wide variety of additional duties including refill management, care gap closure, and most of the duties concerning the EMR—including documentation.
Misra-Hebert et al studied the second approach and found important evidence that using staff in this way does not adversely affect—and may even enhance—documentation previously done entirely by physicians.
This change in the way we approach EMRs involves commitment, as I’ve seen first hand. There needs to be significant training to make this work and there needs to be more staff, since physicians require 2 of these valuable team members to function effectively. (At least that’s been our experience.)
We are in the process of implementing team-based care throughout our 32-location health care system and have found that using CMAs and LPNs to assist with documentation is a “win” for everyone.
1. A win for the patient. Patients immediately notice that their physicians are now able to focus on them during the office visit, since they no longer have to tend to the demands of the computer. In addition, since the CMAs/LPNs are with patients during the entire visit, the patients bond with them and feel the extra support from this relationship.
2. A win for the care team. Physician satisfaction has never been higher. Charts are usually closed at the end of each half-day. There is no need to take work home at night. CMAs/LPNs feel empowered and meaningfully involved in patient care. Their increase in satisfaction mirrors that of the physicians.
3. A win for the system. Not only are quality measures improving, but access improves since this team support increases efficiency. The biggest surprise of all for us was a financial one. We are able to see more patients per day and are billing at a higher level of service, since there is more time to attend to more of the patient’s needs (thanks to the additional team support).
There is much talk about putting joy back into the practice of medicine. But the benchmark of any change needs to be whether it helps our patients. I believe that team documentation does. Happier, less burned-out physicians are able to better focus on patients during their visit. As one patient recently said to me at the end of a visit, “I feel like I’ve got my doctor back.”
That’s something that patients, and doctors alike, can feel good about.
The clerical work involved in managing the electronic medical record (EMR) is clearly not at the top of the skill set for physicians, yet many office-based clinicians find themselves bogged down in this work with no easy way out.
However, practices that are adopting team-based care—where each team member works at the top of his or her skill set—are finding a solution in the form of scribing, or team documentation. This approach can ease that burden and perhaps even help to curb physician burnout in the process. But many questions still surround this approach, notably: What do we know about the quality of this documentation?
Research conducted by Misra-Hebert et al reported on in this issue provides some insight—and reason for optimism. (See “Medical scribes: How do their notes stack up?”) Their study found that scribes’ outpatient notes stack up quite well when compared to those of physicians. And having worked with this approach to documentation, I can attest to its benefits, as well.
Two approaches, one goal. There are 2 different ways that physicians can get help with documentation. One involves the use of trained scribes, who come from a variety of backgrounds and are charged with writing down, or scribing, what the physician says. The other involves training staff, usually certified medical assistants (CMAs) or licensed practical nurses (LPNs), to take on a wide variety of additional duties including refill management, care gap closure, and most of the duties concerning the EMR—including documentation.
Misra-Hebert et al studied the second approach and found important evidence that using staff in this way does not adversely affect—and may even enhance—documentation previously done entirely by physicians.
This change in the way we approach EMRs involves commitment, as I’ve seen first hand. There needs to be significant training to make this work and there needs to be more staff, since physicians require 2 of these valuable team members to function effectively. (At least that’s been our experience.)
We are in the process of implementing team-based care throughout our 32-location health care system and have found that using CMAs and LPNs to assist with documentation is a “win” for everyone.
1. A win for the patient. Patients immediately notice that their physicians are now able to focus on them during the office visit, since they no longer have to tend to the demands of the computer. In addition, since the CMAs/LPNs are with patients during the entire visit, the patients bond with them and feel the extra support from this relationship.
2. A win for the care team. Physician satisfaction has never been higher. Charts are usually closed at the end of each half-day. There is no need to take work home at night. CMAs/LPNs feel empowered and meaningfully involved in patient care. Their increase in satisfaction mirrors that of the physicians.
3. A win for the system. Not only are quality measures improving, but access improves since this team support increases efficiency. The biggest surprise of all for us was a financial one. We are able to see more patients per day and are billing at a higher level of service, since there is more time to attend to more of the patient’s needs (thanks to the additional team support).
There is much talk about putting joy back into the practice of medicine. But the benchmark of any change needs to be whether it helps our patients. I believe that team documentation does. Happier, less burned-out physicians are able to better focus on patients during their visit. As one patient recently said to me at the end of a visit, “I feel like I’ve got my doctor back.”
That’s something that patients, and doctors alike, can feel good about.
The clerical work involved in managing the electronic medical record (EMR) is clearly not at the top of the skill set for physicians, yet many office-based clinicians find themselves bogged down in this work with no easy way out.
However, practices that are adopting team-based care—where each team member works at the top of his or her skill set—are finding a solution in the form of scribing, or team documentation. This approach can ease that burden and perhaps even help to curb physician burnout in the process. But many questions still surround this approach, notably: What do we know about the quality of this documentation?
Research conducted by Misra-Hebert et al reported on in this issue provides some insight—and reason for optimism. (See “Medical scribes: How do their notes stack up?”) Their study found that scribes’ outpatient notes stack up quite well when compared to those of physicians. And having worked with this approach to documentation, I can attest to its benefits, as well.
Two approaches, one goal. There are 2 different ways that physicians can get help with documentation. One involves the use of trained scribes, who come from a variety of backgrounds and are charged with writing down, or scribing, what the physician says. The other involves training staff, usually certified medical assistants (CMAs) or licensed practical nurses (LPNs), to take on a wide variety of additional duties including refill management, care gap closure, and most of the duties concerning the EMR—including documentation.
Misra-Hebert et al studied the second approach and found important evidence that using staff in this way does not adversely affect—and may even enhance—documentation previously done entirely by physicians.
This change in the way we approach EMRs involves commitment, as I’ve seen first hand. There needs to be significant training to make this work and there needs to be more staff, since physicians require 2 of these valuable team members to function effectively. (At least that’s been our experience.)
We are in the process of implementing team-based care throughout our 32-location health care system and have found that using CMAs and LPNs to assist with documentation is a “win” for everyone.
1. A win for the patient. Patients immediately notice that their physicians are now able to focus on them during the office visit, since they no longer have to tend to the demands of the computer. In addition, since the CMAs/LPNs are with patients during the entire visit, the patients bond with them and feel the extra support from this relationship.
2. A win for the care team. Physician satisfaction has never been higher. Charts are usually closed at the end of each half-day. There is no need to take work home at night. CMAs/LPNs feel empowered and meaningfully involved in patient care. Their increase in satisfaction mirrors that of the physicians.
3. A win for the system. Not only are quality measures improving, but access improves since this team support increases efficiency. The biggest surprise of all for us was a financial one. We are able to see more patients per day and are billing at a higher level of service, since there is more time to attend to more of the patient’s needs (thanks to the additional team support).
There is much talk about putting joy back into the practice of medicine. But the benchmark of any change needs to be whether it helps our patients. I believe that team documentation does. Happier, less burned-out physicians are able to better focus on patients during their visit. As one patient recently said to me at the end of a visit, “I feel like I’ve got my doctor back.”
That’s something that patients, and doctors alike, can feel good about.
It is not the critic’s voice that should count
During my 25 years as a defense attorney, I have seen the traumatic impact that the allegation of medical malpractice can have on healthcare providers. And I have seen many times that in the aftermath of a case it remains difficult, if not impossible, for the practitioner to return to the clinical setting unscarred by the process. Although vindication by the jury provides some solace, by itself it does not create healing. Instead, the critic’s voice continues to resonate long after the trial.
During a lawsuit, physicians and other providers are commonly confronted with incidental imperfections in the care they provided, errors in their documentation, or both. Consequently, a provider’s perception of events and ultimately the meaning derived from the experience is shaped less by the valid defenses and opinions of the supportive defense experts than by the inconsequential flaws and errors that can often be found in any medical record.
A RECENT CASE
Recently, I defended a hospital team consisting of a hospitalist, trauma surgeon, three residents, and a nurse. The case involved a 74-year-old man who was admitted to the hospital with pancreatitis of unknown cause. Six days after admission, he died of complications of acute respiratory distress syndrome. The team was accused of causing the patient’s death. Specifically, the plaintiff alleged that although the patient’s liver enzyme levels were improving, his condition was deteriorating, and he ultimately developed hemorrhagic pancreatitis. It was the plaintiff’s contention that proper ongoing evaluation, including computed tomographic imaging, would have led to treatment that would have avoided the worsening of pancreatitis, development of an ileus, and ultimately the insult to his bowel and lungs that they claim caused acute respiratory distress syndrome and death. The patient was survived by his wife and their three children. After his death, hospital representatives and the hospitalist met with her in an effort to explain the events that led to her husband’s death. Unfortunately, these discussions did not ameliorate her feelings of loss and anger. She filed a lawsuit, and 4 years later, the case went to trial.
During the trial, the plaintiff’s attorney highlighted errors in the electronic medical record. Entries had been cut and pasted, saving time, but without updating information that had changed in the interim. The inaccuracies included “assessment: worsening pancreatitis” on a day it was considered to have improved. Another entry contained “persistent fever” on a day when no fever was present. Other mistakes involved notes that contained care plans made after morning rounds that were not revised later in the day after changes in the patient’s condition necessitated a change in the plan. In fact, most references to medication dosing in the progress notes on the last 2 days did not match the medication dosing documented in the medication administration record.
In the end, the plaintiff’s counsel did not convince the jury that the healthcare team had been negligent, but unfortunately, she planted doubt in the minds of the caregivers themselves. Perhaps in part, these doubts were the result of having to defend a bad outcome in the face of criticism that was based solely in retrospect. But the providers’ doubts seemed mostly to emanate from the inadequacies in their documentation as they observed how every entry in a far-from-perfect medical record was scrutinized and then manipulated to challenge its textual integrity—and to portray the healthcare team as unengaged and substandard clinicians.
Despite the team’s high level of engagement and the quality of care they provided, any imperfection—whether a documentation error or a minor omission in some aspect of the care provided to this complex patient—became a source of self-doubt and self-criticism.
THE ELECTRONIC MEDICAL RECORD: A MIXED BLESSING
Documentation failures have long been used to “prove” that physicians are disconnected from the clinical situation. The electronic medical record has not proved to be a strong shield against malpractice allegations. In fact, because the electronic medical record absorbs more of the physician’s time and that of the care team’s members, efforts to save time through work-arounds and shortcuts have increased the risk of errors in entering information.
For instance, drop-down menus have led to wrong selections. Cutting and pasting has led to entries that contain data superseded by clinical events, thus creating contradictions within the record itself, and worse, with the physician’s own testimony pertaining to the basis of the clinical decision-making. And boilerplate language has created difficulties when the language does not completely fit the context or when inapplicable verbiage that fills itself in automatically goes unedited. An emergency department physician I represented at trial had to awkwardly explain that some of the data reported in his physical exam findings were inaccurate because of programmed language and should have been deleted; he had no explanation for his oversight.
But my experience has been that juries can forgive imperfections in documentation and even incidental aspects of care. They want to trust that the clinician was there for, and there with, the patient. This emphasis is what allowed us to defend the case involving the patient with pancreatitis. Clinical judgment means being engaged enough to choose what you pay attention to and to process the data you receive.
Unfortunately, the electronic medical record seems designed more for billing and for guarding against claims of fraud than for communication among clinicians or documenting clinically significant events. Many clinicians believe that redundancy and standardized phraseology have weakened the meaningful use of the medical record, as the clinical information is now of questionable reliability or value or is simply hard to find. Consequently, the electronic medical record has become less effective as a communication tool for providing continuity of care.
More importantly, the electronic medical record too often places the physician in front of a computer, so that the computer becomes the focus, not the patient. Studies suggest that the way the electronic medical record is currently used in the examination room affects the quality of physician-patient communication as well as the physician’s cognitive processing of information. Unless the physician is alert and attuned, the electronic medical record can be a barrier to connection. This not only creates the potential for mistakes, but it can also cause patients to question the quality of care they are getting and to distrust the level of the provider’s engagement. In this context, the likelihood that the patient retains an attorney increases when a bad outcome occurs, avoidable or not.
WHAT PATIENTS WANT FROM PHYSICIANS
When I first began seeing my own primary care physician, her office was 5 minutes from my home. Then she relocated to a practice 15 minutes away. And then, because of office consolidation and acquisition, her office was relocated 40 minutes away.
So why do I still go to her? Her training is not better than that of most internists, and my medical history is not so complex that I require more care than most 55-year-old men. I am only speculating, but I would guess that she is not the most financially productive physician in her group. I know that her transition to the electronic medical record has been difficult. Recently, I asked her about it. Except in some situations, she does not type while taking a history, and she stays totally away from the computer while in the examination room with me. She sits a couple of feet from me, and it feels like the days before the electronic medical record. She is clearly more comfortable listening and taking notes first and worrying about the electronic record later. I imagine she stays later to do her notes than most of the other physicians, or she finishes them at home.
The reason I continue to see her as my primary care physician is that she remains totally engaged during my office visit. What tells me that is not just her avoidance of the computer or her body language, but the depth of questions she asks. My responses often prompt her to look back at an earlier office note, and she will then ask follow-up questions to confirm what she had previously recorded. Her examination is thorough, with testing to confirm and retesting to be sure. Doing this may mean that she has difficulty meeting financial or administrative benchmarks established by her practice. I don’t know. But I have no doubt that the likelihood of her missing something in her clinical care is small, and what I suspect is even smaller is the risk that one of her patients would bring a lawsuit against her, given the time she takes to listen and remain connected throughout the office visit.
STAYING CONNECTED, IN SPITE OF EVERYTHING
My point is not to suggest that everyone must conform to the same practice philosophy, particularly with the economic pressures in the medical field. What I am suggesting is that it is not easy to stay connected in a healthcare system in which the system’s structure is driving physicians and other members of the healthcare team towards disconnection. Quality healthcare means making every effort to remain engaged at all times with your patient’s care, which will reduce the likelihood of a bad outcome and may preserve the physician-patient relationship even when a bad outcome occurs.
In the end, perhaps it is not possible to avoid being named as a defendant in a malpractice case, just as it is not possible to avoid all bad medical outcomes despite exceptional care. In law, as in medicine, there are always factors beyond your control. My aspiration is to find a pathway to get providers through the system unbroken—also not an easy task. But one thing I know is true: the more you can stay engaged in the care you provide and in your documentation, the more you will preclude a plaintiff’s attorney from exploiting the effects of the forces within the system that drive providers toward disconnection. As long as you stay engaged and supported by the knowledge that the care provided was appropriate, it is my hope that the voice of the critic will not count as much in the aftermath of a malpractice case. But more importantly, it may allow you to draw meaning and reconciliation from the fact that throughout the patient’s illness, undeterred by the complexities of today’s healthcare system, you remained the attentive and compassionate healer you hoped to be when you first became a healthcare professional.
During my 25 years as a defense attorney, I have seen the traumatic impact that the allegation of medical malpractice can have on healthcare providers. And I have seen many times that in the aftermath of a case it remains difficult, if not impossible, for the practitioner to return to the clinical setting unscarred by the process. Although vindication by the jury provides some solace, by itself it does not create healing. Instead, the critic’s voice continues to resonate long after the trial.
During a lawsuit, physicians and other providers are commonly confronted with incidental imperfections in the care they provided, errors in their documentation, or both. Consequently, a provider’s perception of events and ultimately the meaning derived from the experience is shaped less by the valid defenses and opinions of the supportive defense experts than by the inconsequential flaws and errors that can often be found in any medical record.
A RECENT CASE
Recently, I defended a hospital team consisting of a hospitalist, trauma surgeon, three residents, and a nurse. The case involved a 74-year-old man who was admitted to the hospital with pancreatitis of unknown cause. Six days after admission, he died of complications of acute respiratory distress syndrome. The team was accused of causing the patient’s death. Specifically, the plaintiff alleged that although the patient’s liver enzyme levels were improving, his condition was deteriorating, and he ultimately developed hemorrhagic pancreatitis. It was the plaintiff’s contention that proper ongoing evaluation, including computed tomographic imaging, would have led to treatment that would have avoided the worsening of pancreatitis, development of an ileus, and ultimately the insult to his bowel and lungs that they claim caused acute respiratory distress syndrome and death. The patient was survived by his wife and their three children. After his death, hospital representatives and the hospitalist met with her in an effort to explain the events that led to her husband’s death. Unfortunately, these discussions did not ameliorate her feelings of loss and anger. She filed a lawsuit, and 4 years later, the case went to trial.
During the trial, the plaintiff’s attorney highlighted errors in the electronic medical record. Entries had been cut and pasted, saving time, but without updating information that had changed in the interim. The inaccuracies included “assessment: worsening pancreatitis” on a day it was considered to have improved. Another entry contained “persistent fever” on a day when no fever was present. Other mistakes involved notes that contained care plans made after morning rounds that were not revised later in the day after changes in the patient’s condition necessitated a change in the plan. In fact, most references to medication dosing in the progress notes on the last 2 days did not match the medication dosing documented in the medication administration record.
In the end, the plaintiff’s counsel did not convince the jury that the healthcare team had been negligent, but unfortunately, she planted doubt in the minds of the caregivers themselves. Perhaps in part, these doubts were the result of having to defend a bad outcome in the face of criticism that was based solely in retrospect. But the providers’ doubts seemed mostly to emanate from the inadequacies in their documentation as they observed how every entry in a far-from-perfect medical record was scrutinized and then manipulated to challenge its textual integrity—and to portray the healthcare team as unengaged and substandard clinicians.
Despite the team’s high level of engagement and the quality of care they provided, any imperfection—whether a documentation error or a minor omission in some aspect of the care provided to this complex patient—became a source of self-doubt and self-criticism.
THE ELECTRONIC MEDICAL RECORD: A MIXED BLESSING
Documentation failures have long been used to “prove” that physicians are disconnected from the clinical situation. The electronic medical record has not proved to be a strong shield against malpractice allegations. In fact, because the electronic medical record absorbs more of the physician’s time and that of the care team’s members, efforts to save time through work-arounds and shortcuts have increased the risk of errors in entering information.
For instance, drop-down menus have led to wrong selections. Cutting and pasting has led to entries that contain data superseded by clinical events, thus creating contradictions within the record itself, and worse, with the physician’s own testimony pertaining to the basis of the clinical decision-making. And boilerplate language has created difficulties when the language does not completely fit the context or when inapplicable verbiage that fills itself in automatically goes unedited. An emergency department physician I represented at trial had to awkwardly explain that some of the data reported in his physical exam findings were inaccurate because of programmed language and should have been deleted; he had no explanation for his oversight.
But my experience has been that juries can forgive imperfections in documentation and even incidental aspects of care. They want to trust that the clinician was there for, and there with, the patient. This emphasis is what allowed us to defend the case involving the patient with pancreatitis. Clinical judgment means being engaged enough to choose what you pay attention to and to process the data you receive.
Unfortunately, the electronic medical record seems designed more for billing and for guarding against claims of fraud than for communication among clinicians or documenting clinically significant events. Many clinicians believe that redundancy and standardized phraseology have weakened the meaningful use of the medical record, as the clinical information is now of questionable reliability or value or is simply hard to find. Consequently, the electronic medical record has become less effective as a communication tool for providing continuity of care.
More importantly, the electronic medical record too often places the physician in front of a computer, so that the computer becomes the focus, not the patient. Studies suggest that the way the electronic medical record is currently used in the examination room affects the quality of physician-patient communication as well as the physician’s cognitive processing of information. Unless the physician is alert and attuned, the electronic medical record can be a barrier to connection. This not only creates the potential for mistakes, but it can also cause patients to question the quality of care they are getting and to distrust the level of the provider’s engagement. In this context, the likelihood that the patient retains an attorney increases when a bad outcome occurs, avoidable or not.
WHAT PATIENTS WANT FROM PHYSICIANS
When I first began seeing my own primary care physician, her office was 5 minutes from my home. Then she relocated to a practice 15 minutes away. And then, because of office consolidation and acquisition, her office was relocated 40 minutes away.
So why do I still go to her? Her training is not better than that of most internists, and my medical history is not so complex that I require more care than most 55-year-old men. I am only speculating, but I would guess that she is not the most financially productive physician in her group. I know that her transition to the electronic medical record has been difficult. Recently, I asked her about it. Except in some situations, she does not type while taking a history, and she stays totally away from the computer while in the examination room with me. She sits a couple of feet from me, and it feels like the days before the electronic medical record. She is clearly more comfortable listening and taking notes first and worrying about the electronic record later. I imagine she stays later to do her notes than most of the other physicians, or she finishes them at home.
The reason I continue to see her as my primary care physician is that she remains totally engaged during my office visit. What tells me that is not just her avoidance of the computer or her body language, but the depth of questions she asks. My responses often prompt her to look back at an earlier office note, and she will then ask follow-up questions to confirm what she had previously recorded. Her examination is thorough, with testing to confirm and retesting to be sure. Doing this may mean that she has difficulty meeting financial or administrative benchmarks established by her practice. I don’t know. But I have no doubt that the likelihood of her missing something in her clinical care is small, and what I suspect is even smaller is the risk that one of her patients would bring a lawsuit against her, given the time she takes to listen and remain connected throughout the office visit.
STAYING CONNECTED, IN SPITE OF EVERYTHING
My point is not to suggest that everyone must conform to the same practice philosophy, particularly with the economic pressures in the medical field. What I am suggesting is that it is not easy to stay connected in a healthcare system in which the system’s structure is driving physicians and other members of the healthcare team towards disconnection. Quality healthcare means making every effort to remain engaged at all times with your patient’s care, which will reduce the likelihood of a bad outcome and may preserve the physician-patient relationship even when a bad outcome occurs.
In the end, perhaps it is not possible to avoid being named as a defendant in a malpractice case, just as it is not possible to avoid all bad medical outcomes despite exceptional care. In law, as in medicine, there are always factors beyond your control. My aspiration is to find a pathway to get providers through the system unbroken—also not an easy task. But one thing I know is true: the more you can stay engaged in the care you provide and in your documentation, the more you will preclude a plaintiff’s attorney from exploiting the effects of the forces within the system that drive providers toward disconnection. As long as you stay engaged and supported by the knowledge that the care provided was appropriate, it is my hope that the voice of the critic will not count as much in the aftermath of a malpractice case. But more importantly, it may allow you to draw meaning and reconciliation from the fact that throughout the patient’s illness, undeterred by the complexities of today’s healthcare system, you remained the attentive and compassionate healer you hoped to be when you first became a healthcare professional.
During my 25 years as a defense attorney, I have seen the traumatic impact that the allegation of medical malpractice can have on healthcare providers. And I have seen many times that in the aftermath of a case it remains difficult, if not impossible, for the practitioner to return to the clinical setting unscarred by the process. Although vindication by the jury provides some solace, by itself it does not create healing. Instead, the critic’s voice continues to resonate long after the trial.
During a lawsuit, physicians and other providers are commonly confronted with incidental imperfections in the care they provided, errors in their documentation, or both. Consequently, a provider’s perception of events and ultimately the meaning derived from the experience is shaped less by the valid defenses and opinions of the supportive defense experts than by the inconsequential flaws and errors that can often be found in any medical record.
A RECENT CASE
Recently, I defended a hospital team consisting of a hospitalist, trauma surgeon, three residents, and a nurse. The case involved a 74-year-old man who was admitted to the hospital with pancreatitis of unknown cause. Six days after admission, he died of complications of acute respiratory distress syndrome. The team was accused of causing the patient’s death. Specifically, the plaintiff alleged that although the patient’s liver enzyme levels were improving, his condition was deteriorating, and he ultimately developed hemorrhagic pancreatitis. It was the plaintiff’s contention that proper ongoing evaluation, including computed tomographic imaging, would have led to treatment that would have avoided the worsening of pancreatitis, development of an ileus, and ultimately the insult to his bowel and lungs that they claim caused acute respiratory distress syndrome and death. The patient was survived by his wife and their three children. After his death, hospital representatives and the hospitalist met with her in an effort to explain the events that led to her husband’s death. Unfortunately, these discussions did not ameliorate her feelings of loss and anger. She filed a lawsuit, and 4 years later, the case went to trial.
During the trial, the plaintiff’s attorney highlighted errors in the electronic medical record. Entries had been cut and pasted, saving time, but without updating information that had changed in the interim. The inaccuracies included “assessment: worsening pancreatitis” on a day it was considered to have improved. Another entry contained “persistent fever” on a day when no fever was present. Other mistakes involved notes that contained care plans made after morning rounds that were not revised later in the day after changes in the patient’s condition necessitated a change in the plan. In fact, most references to medication dosing in the progress notes on the last 2 days did not match the medication dosing documented in the medication administration record.
In the end, the plaintiff’s counsel did not convince the jury that the healthcare team had been negligent, but unfortunately, she planted doubt in the minds of the caregivers themselves. Perhaps in part, these doubts were the result of having to defend a bad outcome in the face of criticism that was based solely in retrospect. But the providers’ doubts seemed mostly to emanate from the inadequacies in their documentation as they observed how every entry in a far-from-perfect medical record was scrutinized and then manipulated to challenge its textual integrity—and to portray the healthcare team as unengaged and substandard clinicians.
Despite the team’s high level of engagement and the quality of care they provided, any imperfection—whether a documentation error or a minor omission in some aspect of the care provided to this complex patient—became a source of self-doubt and self-criticism.
THE ELECTRONIC MEDICAL RECORD: A MIXED BLESSING
Documentation failures have long been used to “prove” that physicians are disconnected from the clinical situation. The electronic medical record has not proved to be a strong shield against malpractice allegations. In fact, because the electronic medical record absorbs more of the physician’s time and that of the care team’s members, efforts to save time through work-arounds and shortcuts have increased the risk of errors in entering information.
For instance, drop-down menus have led to wrong selections. Cutting and pasting has led to entries that contain data superseded by clinical events, thus creating contradictions within the record itself, and worse, with the physician’s own testimony pertaining to the basis of the clinical decision-making. And boilerplate language has created difficulties when the language does not completely fit the context or when inapplicable verbiage that fills itself in automatically goes unedited. An emergency department physician I represented at trial had to awkwardly explain that some of the data reported in his physical exam findings were inaccurate because of programmed language and should have been deleted; he had no explanation for his oversight.
But my experience has been that juries can forgive imperfections in documentation and even incidental aspects of care. They want to trust that the clinician was there for, and there with, the patient. This emphasis is what allowed us to defend the case involving the patient with pancreatitis. Clinical judgment means being engaged enough to choose what you pay attention to and to process the data you receive.
Unfortunately, the electronic medical record seems designed more for billing and for guarding against claims of fraud than for communication among clinicians or documenting clinically significant events. Many clinicians believe that redundancy and standardized phraseology have weakened the meaningful use of the medical record, as the clinical information is now of questionable reliability or value or is simply hard to find. Consequently, the electronic medical record has become less effective as a communication tool for providing continuity of care.
More importantly, the electronic medical record too often places the physician in front of a computer, so that the computer becomes the focus, not the patient. Studies suggest that the way the electronic medical record is currently used in the examination room affects the quality of physician-patient communication as well as the physician’s cognitive processing of information. Unless the physician is alert and attuned, the electronic medical record can be a barrier to connection. This not only creates the potential for mistakes, but it can also cause patients to question the quality of care they are getting and to distrust the level of the provider’s engagement. In this context, the likelihood that the patient retains an attorney increases when a bad outcome occurs, avoidable or not.
WHAT PATIENTS WANT FROM PHYSICIANS
When I first began seeing my own primary care physician, her office was 5 minutes from my home. Then she relocated to a practice 15 minutes away. And then, because of office consolidation and acquisition, her office was relocated 40 minutes away.
So why do I still go to her? Her training is not better than that of most internists, and my medical history is not so complex that I require more care than most 55-year-old men. I am only speculating, but I would guess that she is not the most financially productive physician in her group. I know that her transition to the electronic medical record has been difficult. Recently, I asked her about it. Except in some situations, she does not type while taking a history, and she stays totally away from the computer while in the examination room with me. She sits a couple of feet from me, and it feels like the days before the electronic medical record. She is clearly more comfortable listening and taking notes first and worrying about the electronic record later. I imagine she stays later to do her notes than most of the other physicians, or she finishes them at home.
The reason I continue to see her as my primary care physician is that she remains totally engaged during my office visit. What tells me that is not just her avoidance of the computer or her body language, but the depth of questions she asks. My responses often prompt her to look back at an earlier office note, and she will then ask follow-up questions to confirm what she had previously recorded. Her examination is thorough, with testing to confirm and retesting to be sure. Doing this may mean that she has difficulty meeting financial or administrative benchmarks established by her practice. I don’t know. But I have no doubt that the likelihood of her missing something in her clinical care is small, and what I suspect is even smaller is the risk that one of her patients would bring a lawsuit against her, given the time she takes to listen and remain connected throughout the office visit.
STAYING CONNECTED, IN SPITE OF EVERYTHING
My point is not to suggest that everyone must conform to the same practice philosophy, particularly with the economic pressures in the medical field. What I am suggesting is that it is not easy to stay connected in a healthcare system in which the system’s structure is driving physicians and other members of the healthcare team towards disconnection. Quality healthcare means making every effort to remain engaged at all times with your patient’s care, which will reduce the likelihood of a bad outcome and may preserve the physician-patient relationship even when a bad outcome occurs.
In the end, perhaps it is not possible to avoid being named as a defendant in a malpractice case, just as it is not possible to avoid all bad medical outcomes despite exceptional care. In law, as in medicine, there are always factors beyond your control. My aspiration is to find a pathway to get providers through the system unbroken—also not an easy task. But one thing I know is true: the more you can stay engaged in the care you provide and in your documentation, the more you will preclude a plaintiff’s attorney from exploiting the effects of the forces within the system that drive providers toward disconnection. As long as you stay engaged and supported by the knowledge that the care provided was appropriate, it is my hope that the voice of the critic will not count as much in the aftermath of a malpractice case. But more importantly, it may allow you to draw meaning and reconciliation from the fact that throughout the patient’s illness, undeterred by the complexities of today’s healthcare system, you remained the attentive and compassionate healer you hoped to be when you first became a healthcare professional.
The hunger game
How do you feel about hunger? Do you trust in its power? Having written one book on picky eating based solely on my mother’s wisdom, supplemented with a scanty amount of Internet-based research, I have spent and continue to spend a good bit of time thinking about hunger.
I have concluded that it is a very powerful force and that when a child gets hungry enough, he will eat, even foods that he has previously rejected. It is that assumption that is at the core of my advice to parents of picky eaters. I suspect that many of you share that same philosophy and recommend a strategy that is heavy on patience. Of course the problem lies in getting parents to adopt that attitude and accept the fact that if they just present a healthy diet and step back, hunger will eventually win, and the child will eat.
However, the devil is in the details. Have the parents set rules that will prevent the child from overdrinking? Have they really stopped talking about what the child, and everyone else in the family, is or isn’t eating? Are the parents setting good examples with their own eating habits and comments about food?
Because 99% of my patient population have been healthy, I have always felt comfortable relying on the power of hunger to win the battle over picky eating. If properly managed, none of my patients was going to die or suffer permanent consequences from picky eating. However, I have always wondered whether hunger could be leveraged to safely manage selective eating in children with serious health problems. I have a suspicion that it would succeed, but luckily I have never been presented with a case to test my hunch.
I recently read a very personal account written by the mother of a child with severe congenital cardiac disease that supports my gut feeling that when carefully monitored, starvation can be an effective strategy in managing selective eating (“When Your Baby Won’t Eat,” by Virginia Sole-Smith, The New York Times Magazine, Feb. 4, 2016). Three surgeries in the first few months of life necessitated that the child be fed by gavage. Attempts at breastfeeding failed, as it often does in situations like this. Struggles with gavage tube placement at home became such an emotionally traumatic ordeal that eventually a gastrostomy tube was placed when the child was 6 months old.
The family was led to believe that an important window in the child’s oral development had closed as a result of interventions necessitated by the child’s cardiac malformations. Although she was neurologically and physically capable of eating, getting her to do so was going to require long-term behavior modification, and there was no guarantee that this approach would completely undo what bad luck and prior management strategies had created. She might never relate to food as a normal child does.
After several attempts at behavior management using one-to-one reinforcement, this mother began to do some research. She discovered that of the nearly 30 feeding programs in children’s hospitals and private clinics, almost all use variations of a similar behavior modification strategy that had not worked for her daughter. As she observed: “This behavioral model presumes that children who don’t eat need external motivation.”
Eventually, the family found help in one of the few feeding programs in the United States that has adopted a dramatically different “child-centered” approach in which “therapists believe that all children have some internal motivation to eat, as well as an innate ability to effectively self-regulate their intake.” The solution to this child’s problem didn’t occur overnight. It began by exposing the child to a variety of foods in situations free of attempts to get her to eat – no coercion or rewards, regardless of how subtle they might have seemed. Once the child was experimenting with food, her tube feedings were gradually decreased in volume and caloric content. And, voila! Hunger won and the child began meeting her total nutritional needs by eating, in some cases with gusto.
Of course I was easy to convince because the results confirmed my hunch. But, do you believe that hunger can and should be used as the centerpiece in the management of selective eating, even in cases well beyond the parameters of garden variety picky eating? Are you willing to play the hunger game along with me?
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”
How do you feel about hunger? Do you trust in its power? Having written one book on picky eating based solely on my mother’s wisdom, supplemented with a scanty amount of Internet-based research, I have spent and continue to spend a good bit of time thinking about hunger.
I have concluded that it is a very powerful force and that when a child gets hungry enough, he will eat, even foods that he has previously rejected. It is that assumption that is at the core of my advice to parents of picky eaters. I suspect that many of you share that same philosophy and recommend a strategy that is heavy on patience. Of course the problem lies in getting parents to adopt that attitude and accept the fact that if they just present a healthy diet and step back, hunger will eventually win, and the child will eat.
However, the devil is in the details. Have the parents set rules that will prevent the child from overdrinking? Have they really stopped talking about what the child, and everyone else in the family, is or isn’t eating? Are the parents setting good examples with their own eating habits and comments about food?
Because 99% of my patient population have been healthy, I have always felt comfortable relying on the power of hunger to win the battle over picky eating. If properly managed, none of my patients was going to die or suffer permanent consequences from picky eating. However, I have always wondered whether hunger could be leveraged to safely manage selective eating in children with serious health problems. I have a suspicion that it would succeed, but luckily I have never been presented with a case to test my hunch.
I recently read a very personal account written by the mother of a child with severe congenital cardiac disease that supports my gut feeling that when carefully monitored, starvation can be an effective strategy in managing selective eating (“When Your Baby Won’t Eat,” by Virginia Sole-Smith, The New York Times Magazine, Feb. 4, 2016). Three surgeries in the first few months of life necessitated that the child be fed by gavage. Attempts at breastfeeding failed, as it often does in situations like this. Struggles with gavage tube placement at home became such an emotionally traumatic ordeal that eventually a gastrostomy tube was placed when the child was 6 months old.
The family was led to believe that an important window in the child’s oral development had closed as a result of interventions necessitated by the child’s cardiac malformations. Although she was neurologically and physically capable of eating, getting her to do so was going to require long-term behavior modification, and there was no guarantee that this approach would completely undo what bad luck and prior management strategies had created. She might never relate to food as a normal child does.
After several attempts at behavior management using one-to-one reinforcement, this mother began to do some research. She discovered that of the nearly 30 feeding programs in children’s hospitals and private clinics, almost all use variations of a similar behavior modification strategy that had not worked for her daughter. As she observed: “This behavioral model presumes that children who don’t eat need external motivation.”
Eventually, the family found help in one of the few feeding programs in the United States that has adopted a dramatically different “child-centered” approach in which “therapists believe that all children have some internal motivation to eat, as well as an innate ability to effectively self-regulate their intake.” The solution to this child’s problem didn’t occur overnight. It began by exposing the child to a variety of foods in situations free of attempts to get her to eat – no coercion or rewards, regardless of how subtle they might have seemed. Once the child was experimenting with food, her tube feedings were gradually decreased in volume and caloric content. And, voila! Hunger won and the child began meeting her total nutritional needs by eating, in some cases with gusto.
Of course I was easy to convince because the results confirmed my hunch. But, do you believe that hunger can and should be used as the centerpiece in the management of selective eating, even in cases well beyond the parameters of garden variety picky eating? Are you willing to play the hunger game along with me?
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”
How do you feel about hunger? Do you trust in its power? Having written one book on picky eating based solely on my mother’s wisdom, supplemented with a scanty amount of Internet-based research, I have spent and continue to spend a good bit of time thinking about hunger.
I have concluded that it is a very powerful force and that when a child gets hungry enough, he will eat, even foods that he has previously rejected. It is that assumption that is at the core of my advice to parents of picky eaters. I suspect that many of you share that same philosophy and recommend a strategy that is heavy on patience. Of course the problem lies in getting parents to adopt that attitude and accept the fact that if they just present a healthy diet and step back, hunger will eventually win, and the child will eat.
However, the devil is in the details. Have the parents set rules that will prevent the child from overdrinking? Have they really stopped talking about what the child, and everyone else in the family, is or isn’t eating? Are the parents setting good examples with their own eating habits and comments about food?
Because 99% of my patient population have been healthy, I have always felt comfortable relying on the power of hunger to win the battle over picky eating. If properly managed, none of my patients was going to die or suffer permanent consequences from picky eating. However, I have always wondered whether hunger could be leveraged to safely manage selective eating in children with serious health problems. I have a suspicion that it would succeed, but luckily I have never been presented with a case to test my hunch.
I recently read a very personal account written by the mother of a child with severe congenital cardiac disease that supports my gut feeling that when carefully monitored, starvation can be an effective strategy in managing selective eating (“When Your Baby Won’t Eat,” by Virginia Sole-Smith, The New York Times Magazine, Feb. 4, 2016). Three surgeries in the first few months of life necessitated that the child be fed by gavage. Attempts at breastfeeding failed, as it often does in situations like this. Struggles with gavage tube placement at home became such an emotionally traumatic ordeal that eventually a gastrostomy tube was placed when the child was 6 months old.
The family was led to believe that an important window in the child’s oral development had closed as a result of interventions necessitated by the child’s cardiac malformations. Although she was neurologically and physically capable of eating, getting her to do so was going to require long-term behavior modification, and there was no guarantee that this approach would completely undo what bad luck and prior management strategies had created. She might never relate to food as a normal child does.
After several attempts at behavior management using one-to-one reinforcement, this mother began to do some research. She discovered that of the nearly 30 feeding programs in children’s hospitals and private clinics, almost all use variations of a similar behavior modification strategy that had not worked for her daughter. As she observed: “This behavioral model presumes that children who don’t eat need external motivation.”
Eventually, the family found help in one of the few feeding programs in the United States that has adopted a dramatically different “child-centered” approach in which “therapists believe that all children have some internal motivation to eat, as well as an innate ability to effectively self-regulate their intake.” The solution to this child’s problem didn’t occur overnight. It began by exposing the child to a variety of foods in situations free of attempts to get her to eat – no coercion or rewards, regardless of how subtle they might have seemed. Once the child was experimenting with food, her tube feedings were gradually decreased in volume and caloric content. And, voila! Hunger won and the child began meeting her total nutritional needs by eating, in some cases with gusto.
Of course I was easy to convince because the results confirmed my hunch. But, do you believe that hunger can and should be used as the centerpiece in the management of selective eating, even in cases well beyond the parameters of garden variety picky eating? Are you willing to play the hunger game along with me?
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”
New data points to slower course of labor
Only recently has evidence emerged that challenges our long-held understanding of “normal” and “abnormal” labor. We now know there is a much wider range of normal labor progress in women who go on to have good labor outcomes. We have a new labor curve to guide us – one that shows us, for example, that active labor occurs most commonly after 6 cm dilation rather than 4 cm as we’d previously thought.
By appreciating this new labor paradigm, we can potentially have a significant impact on the cesarean rate in the United States. While our use of the older labor curve is not the only reason for the rise in cesarean deliveries over the last 30 years, it very likely has played a role. A study published in 2011 of more than 32,000 live births at a major academic hospital demonstrated that one of the most common reasons for primary cesarean is abnormal labor or arrest (Obstet Gynecol. 2011 Jul;118[1]:29-38).
Another study by the Consortium on Safe Labor – an analysis of labor and delivery information from more than 228,000 women across the United States – showed that half of the cesarean deliveries performed for dystocia in women undergoing labor induction were performed before 6 cm of cervical dilation and relatively soon after the previous cervical examination (Am J Obstet Gynecol. 2010 Oct; 203[4]: 326.e1–326.e10).
Our new labor paradigm brings to the forefront a host of new issues and questions about how we can best manage labor to optimize outcomes. In a way, recent discoveries about labor progress have highlighted a dearth of evidence and made “old” issues in labor management seem new and urgent.
As we strive to learn more, however, we are challenged to change our practices and behavior at the bedside with the evidence we currently have. By appreciating both the new labor curve and our current understanding of how labor induction, obesity, and other patient characteristics and clinical conditions can affect labor progress, we can expect that many women will simply progress much more slowly than was historically expected.
As long as we have indications of the well-being of the baby and the well-being of the mother, a slower but progressive labor in the first stage should not prompt us to intervene. We should no longer apply the standards of active-phase progress – standards that have traditionally driven our diagnoses of labor dystocia – until the patient has achieved 6 cm of dilation.
The labor curve that had shaped our thinking about normal and abnormal labor progress until recently was developed by Dr. Emanuel Friedman. Based on findings from a prospective cohort study of 500 nulliparous women, Dr. Friedman plotted labor progress with centimeters of cervical dilation on the Y-axis and time on the X-axis, and divided labor into several stages and phases. In this curve, the rate of change of cervical dilation over time started increasing significantly at 4 cm; this period of increasing slope defined the active phase of labor.
Abnormal labor progress in the active phase was then defined, based on the 95th percentile, as cervical dilation of less than 1.2 cm per hour for nulliparous women and less than 1.5 cm per hour for multiparous women. Based on Dr. Friedman’s work, a woman was deemed to be in active-phase arrest when she had no cervical changes for 2 hours or more while having adequate uterine contractions and cervical dilation of at least 4 cm. These concepts came to govern labor management.
The paradigm shifted when the Consortium on Safe Labor reported in 2010 on a retrospective cohort study of more than 62,000 women at 19 U.S. hospitals. The women had a singleton term gestation, spontaneous labor, vertex presentation, vaginal delivery, and a normal perinatal outcome. In their analysis of labor and delivery information, Dr. Jun Zhang of the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development and his colleagues accounted for the fact that the exact times of cervical change are unknown.
They used modern statistical methods and analytical tools that took into account the specific nature of cervical dilation data – that cervical measurements are interval-censored (we never know the exact time when a woman’s cervix changes) and that multiple exams of the cervix in the same patient are not independent (Obstet Gynecol. 2010 Dec;116[6]:1281-7).
The methodology used in the Consortium study accounted for both the interval-censored and repeated-measures nature of cervical dilation data. It thus addressed analytical flaws in the previous approach to labor data, which was purely descriptive of the exam findings and did not consider the nature of the data itself.
Under the new analysis and in the larger, contemporary population of patients, the period of increasing slope was found to occur most commonly after 6 cm, not 4 cm. The slowest 5% of nulliparous women had cervical dilation of 0.4 cm per hour (with the median at 1.9 cm per hour), compared with 1.2 cm per hour (with a median of 3.0 cm per hour) as in the Friedman data.
Dr. Zhang’s study showed us that labor may take more than 6 hours to progress from 4 to 5 cm dilation, and more than 3 hours to progress from 5 to 6 cm dilation – a rate of progress that is significantly slower than what Dr. Friedman had described. The new data showed us, moreover, that from 4 cm-6 cm dilation, nulliparous and multiparous women progressed similarly slowly. Beyond 6 cm, multiparous women dilated more rapidly, with a steeper acceleration phase than previously described.
A consensus statement published in 2014 by the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) on “Safe Prevention of the Primary Cesarean Delivery” encourages use of the Consortium data to revisit the definition of labor dystocia. While the data “do not directly address an optimal duration for the diagnosis of active-phase protraction or labor arrest, [they] do suggest that neither should be diagnosed before 6 cm dilation” (Obstet Gynecol. 2014 Mar;123[3]:693-711).
The ACOG-SMFM statement makes a series of recommendations for managing the first and second stages of labor, based not only on the Consortium data but on a broader literature review. It recommends that if mother and fetus appear well, cesarean delivery for active-phase arrest in the first stage of labor be reserved for women of at least 6 cm of dilation with ruptured membranes who fail to progress despite 4 hours of adequate uterine activity, or at least 6 hours of oxytocin administration with inadequate uterine activity and no cervical change.
Regarding the latent phase of labor, the statement says that most women with a prolonged latent phase ultimately will enter the active phase with expectant management. It advises that a prolonged latent phase (for example, greater than 20 hours in nulliparous women and greater than 14 hours in multiparous women) should not be an isolated indication for cesarean delivery.
The consensus statement also recognizes recent data showing that women who undergo labor induction have an even slower “normal” course of labor, particularly a longer latent phase, than women who labor spontaneously. A retrospective cohort study of more than 5,000 women, for instance, found that before 6 cm, women whose labor is induced can spend up to 10 hours to achieve each 1 cm of dilation (Obstet Gynecol. 2012 Jun;119[6]:1113-8).
As long as maternal and fetal status are reassuring, the statement says, cesarean deliveries for failed induction of labor in the latent phase can be avoided by allowing longer durations of the latent phase (up to 24 hours) and by requiring that oxytocin be administered for 12-18 hours after membrane rupture before deeming induction a failure.
Each of these described recommendations were graded in the ACOG-SMFM consensus document as “strong” recommendations with “moderate quality evidence.”
Examining our standards
Moving forward, we must further develop and define our thresholds for identifying who will most benefit from a cesarean delivery. We have many specific aspects of labor management to address as well, such as the optimal timing of artificial membrane rupture and the safety and efficacy of different oxytocin protocols. We may also want to revisit recommendations for serial cervical assessment, possibly adjusting the intervals given our understanding of the new labor curve.
Under the new labor paradigm, moreover, we must think not only about the clinical decisions we make at the bedside, but about the decisions we make early in the labor management process.
The timing of admission is one such decision. A statement published in 2012 on “Preventing the First Cesarean Delivery” by ACOG, SMFM, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development advises us to avoid admittance of women during the early latent phase of labor (Obstet Gynecol. 2012 Nov;120[5]:1181-93).
It may even be advisable that we consider admittance at higher cervical dilation. A study published this year shows that women admitted at less than 6 cm of dilation had an increased risk of cesarean delivery, compared with women admitted at higher cervical dilation (Am J Perinatol. 2016 Jan;33[2]:188-94). We have more to learn, but certainly, given what we know now about labor progress and the start of active labor, the timing of admission is an important factor to consider.
The second stage of labor, defined as the interval from complete cervical dilation through delivery of the fetus, presents many questions as well. There is a paucity of quality published data concerning what is normal, how long the stage should last, and how we should manage it. Historically, we have been taught to allow 2 hours of pushing for nulliparous women and 1 hour for multiparous women, when epidural anesthesia has not been administered, and to add an additional hour when epidural is used.
The 2014 ACOG-SMFM consensus statement recommends extending each of these limits by an hour, if maternal and fetal conditions permit, so that we allow at least 3 hours of pushing for nulliparous women and at least 2 hours for multiparous women before diagnosing arrest of labor in the second stage. Longer durations may be appropriate with the use of epidural anesthesia and on an individualized basis.
At this time, it is unclear whether there is any absolute maximum length of time beyond which all women in the second stage of labor should undergo cesarean delivery. We also still do not know the optimal technique for managing maternal pushing during the second stage. Should women with an epidural push right away or should they allow for a period of spontaneous descent? Many of the high-quality studies reported thus far that compare delayed and immediate pushing have limited applicability to current practice because they involved now-obsolete midpelvic forceps deliveries. A large multicenter randomized trial currently underway should provide us with some answers.
Dr. Cahill is an associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University School of Medicine in St. Louis. She reported having no relevant financial disclosures.
Only recently has evidence emerged that challenges our long-held understanding of “normal” and “abnormal” labor. We now know there is a much wider range of normal labor progress in women who go on to have good labor outcomes. We have a new labor curve to guide us – one that shows us, for example, that active labor occurs most commonly after 6 cm dilation rather than 4 cm as we’d previously thought.
By appreciating this new labor paradigm, we can potentially have a significant impact on the cesarean rate in the United States. While our use of the older labor curve is not the only reason for the rise in cesarean deliveries over the last 30 years, it very likely has played a role. A study published in 2011 of more than 32,000 live births at a major academic hospital demonstrated that one of the most common reasons for primary cesarean is abnormal labor or arrest (Obstet Gynecol. 2011 Jul;118[1]:29-38).
Another study by the Consortium on Safe Labor – an analysis of labor and delivery information from more than 228,000 women across the United States – showed that half of the cesarean deliveries performed for dystocia in women undergoing labor induction were performed before 6 cm of cervical dilation and relatively soon after the previous cervical examination (Am J Obstet Gynecol. 2010 Oct; 203[4]: 326.e1–326.e10).
Our new labor paradigm brings to the forefront a host of new issues and questions about how we can best manage labor to optimize outcomes. In a way, recent discoveries about labor progress have highlighted a dearth of evidence and made “old” issues in labor management seem new and urgent.
As we strive to learn more, however, we are challenged to change our practices and behavior at the bedside with the evidence we currently have. By appreciating both the new labor curve and our current understanding of how labor induction, obesity, and other patient characteristics and clinical conditions can affect labor progress, we can expect that many women will simply progress much more slowly than was historically expected.
As long as we have indications of the well-being of the baby and the well-being of the mother, a slower but progressive labor in the first stage should not prompt us to intervene. We should no longer apply the standards of active-phase progress – standards that have traditionally driven our diagnoses of labor dystocia – until the patient has achieved 6 cm of dilation.
The labor curve that had shaped our thinking about normal and abnormal labor progress until recently was developed by Dr. Emanuel Friedman. Based on findings from a prospective cohort study of 500 nulliparous women, Dr. Friedman plotted labor progress with centimeters of cervical dilation on the Y-axis and time on the X-axis, and divided labor into several stages and phases. In this curve, the rate of change of cervical dilation over time started increasing significantly at 4 cm; this period of increasing slope defined the active phase of labor.
Abnormal labor progress in the active phase was then defined, based on the 95th percentile, as cervical dilation of less than 1.2 cm per hour for nulliparous women and less than 1.5 cm per hour for multiparous women. Based on Dr. Friedman’s work, a woman was deemed to be in active-phase arrest when she had no cervical changes for 2 hours or more while having adequate uterine contractions and cervical dilation of at least 4 cm. These concepts came to govern labor management.
The paradigm shifted when the Consortium on Safe Labor reported in 2010 on a retrospective cohort study of more than 62,000 women at 19 U.S. hospitals. The women had a singleton term gestation, spontaneous labor, vertex presentation, vaginal delivery, and a normal perinatal outcome. In their analysis of labor and delivery information, Dr. Jun Zhang of the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development and his colleagues accounted for the fact that the exact times of cervical change are unknown.
They used modern statistical methods and analytical tools that took into account the specific nature of cervical dilation data – that cervical measurements are interval-censored (we never know the exact time when a woman’s cervix changes) and that multiple exams of the cervix in the same patient are not independent (Obstet Gynecol. 2010 Dec;116[6]:1281-7).
The methodology used in the Consortium study accounted for both the interval-censored and repeated-measures nature of cervical dilation data. It thus addressed analytical flaws in the previous approach to labor data, which was purely descriptive of the exam findings and did not consider the nature of the data itself.
Under the new analysis and in the larger, contemporary population of patients, the period of increasing slope was found to occur most commonly after 6 cm, not 4 cm. The slowest 5% of nulliparous women had cervical dilation of 0.4 cm per hour (with the median at 1.9 cm per hour), compared with 1.2 cm per hour (with a median of 3.0 cm per hour) as in the Friedman data.
Dr. Zhang’s study showed us that labor may take more than 6 hours to progress from 4 to 5 cm dilation, and more than 3 hours to progress from 5 to 6 cm dilation – a rate of progress that is significantly slower than what Dr. Friedman had described. The new data showed us, moreover, that from 4 cm-6 cm dilation, nulliparous and multiparous women progressed similarly slowly. Beyond 6 cm, multiparous women dilated more rapidly, with a steeper acceleration phase than previously described.
A consensus statement published in 2014 by the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) on “Safe Prevention of the Primary Cesarean Delivery” encourages use of the Consortium data to revisit the definition of labor dystocia. While the data “do not directly address an optimal duration for the diagnosis of active-phase protraction or labor arrest, [they] do suggest that neither should be diagnosed before 6 cm dilation” (Obstet Gynecol. 2014 Mar;123[3]:693-711).
The ACOG-SMFM statement makes a series of recommendations for managing the first and second stages of labor, based not only on the Consortium data but on a broader literature review. It recommends that if mother and fetus appear well, cesarean delivery for active-phase arrest in the first stage of labor be reserved for women of at least 6 cm of dilation with ruptured membranes who fail to progress despite 4 hours of adequate uterine activity, or at least 6 hours of oxytocin administration with inadequate uterine activity and no cervical change.
Regarding the latent phase of labor, the statement says that most women with a prolonged latent phase ultimately will enter the active phase with expectant management. It advises that a prolonged latent phase (for example, greater than 20 hours in nulliparous women and greater than 14 hours in multiparous women) should not be an isolated indication for cesarean delivery.
The consensus statement also recognizes recent data showing that women who undergo labor induction have an even slower “normal” course of labor, particularly a longer latent phase, than women who labor spontaneously. A retrospective cohort study of more than 5,000 women, for instance, found that before 6 cm, women whose labor is induced can spend up to 10 hours to achieve each 1 cm of dilation (Obstet Gynecol. 2012 Jun;119[6]:1113-8).
As long as maternal and fetal status are reassuring, the statement says, cesarean deliveries for failed induction of labor in the latent phase can be avoided by allowing longer durations of the latent phase (up to 24 hours) and by requiring that oxytocin be administered for 12-18 hours after membrane rupture before deeming induction a failure.
Each of these described recommendations were graded in the ACOG-SMFM consensus document as “strong” recommendations with “moderate quality evidence.”
Examining our standards
Moving forward, we must further develop and define our thresholds for identifying who will most benefit from a cesarean delivery. We have many specific aspects of labor management to address as well, such as the optimal timing of artificial membrane rupture and the safety and efficacy of different oxytocin protocols. We may also want to revisit recommendations for serial cervical assessment, possibly adjusting the intervals given our understanding of the new labor curve.
Under the new labor paradigm, moreover, we must think not only about the clinical decisions we make at the bedside, but about the decisions we make early in the labor management process.
The timing of admission is one such decision. A statement published in 2012 on “Preventing the First Cesarean Delivery” by ACOG, SMFM, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development advises us to avoid admittance of women during the early latent phase of labor (Obstet Gynecol. 2012 Nov;120[5]:1181-93).
It may even be advisable that we consider admittance at higher cervical dilation. A study published this year shows that women admitted at less than 6 cm of dilation had an increased risk of cesarean delivery, compared with women admitted at higher cervical dilation (Am J Perinatol. 2016 Jan;33[2]:188-94). We have more to learn, but certainly, given what we know now about labor progress and the start of active labor, the timing of admission is an important factor to consider.
The second stage of labor, defined as the interval from complete cervical dilation through delivery of the fetus, presents many questions as well. There is a paucity of quality published data concerning what is normal, how long the stage should last, and how we should manage it. Historically, we have been taught to allow 2 hours of pushing for nulliparous women and 1 hour for multiparous women, when epidural anesthesia has not been administered, and to add an additional hour when epidural is used.
The 2014 ACOG-SMFM consensus statement recommends extending each of these limits by an hour, if maternal and fetal conditions permit, so that we allow at least 3 hours of pushing for nulliparous women and at least 2 hours for multiparous women before diagnosing arrest of labor in the second stage. Longer durations may be appropriate with the use of epidural anesthesia and on an individualized basis.
At this time, it is unclear whether there is any absolute maximum length of time beyond which all women in the second stage of labor should undergo cesarean delivery. We also still do not know the optimal technique for managing maternal pushing during the second stage. Should women with an epidural push right away or should they allow for a period of spontaneous descent? Many of the high-quality studies reported thus far that compare delayed and immediate pushing have limited applicability to current practice because they involved now-obsolete midpelvic forceps deliveries. A large multicenter randomized trial currently underway should provide us with some answers.
Dr. Cahill is an associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University School of Medicine in St. Louis. She reported having no relevant financial disclosures.
Only recently has evidence emerged that challenges our long-held understanding of “normal” and “abnormal” labor. We now know there is a much wider range of normal labor progress in women who go on to have good labor outcomes. We have a new labor curve to guide us – one that shows us, for example, that active labor occurs most commonly after 6 cm dilation rather than 4 cm as we’d previously thought.
By appreciating this new labor paradigm, we can potentially have a significant impact on the cesarean rate in the United States. While our use of the older labor curve is not the only reason for the rise in cesarean deliveries over the last 30 years, it very likely has played a role. A study published in 2011 of more than 32,000 live births at a major academic hospital demonstrated that one of the most common reasons for primary cesarean is abnormal labor or arrest (Obstet Gynecol. 2011 Jul;118[1]:29-38).
Another study by the Consortium on Safe Labor – an analysis of labor and delivery information from more than 228,000 women across the United States – showed that half of the cesarean deliveries performed for dystocia in women undergoing labor induction were performed before 6 cm of cervical dilation and relatively soon after the previous cervical examination (Am J Obstet Gynecol. 2010 Oct; 203[4]: 326.e1–326.e10).
Our new labor paradigm brings to the forefront a host of new issues and questions about how we can best manage labor to optimize outcomes. In a way, recent discoveries about labor progress have highlighted a dearth of evidence and made “old” issues in labor management seem new and urgent.
As we strive to learn more, however, we are challenged to change our practices and behavior at the bedside with the evidence we currently have. By appreciating both the new labor curve and our current understanding of how labor induction, obesity, and other patient characteristics and clinical conditions can affect labor progress, we can expect that many women will simply progress much more slowly than was historically expected.
As long as we have indications of the well-being of the baby and the well-being of the mother, a slower but progressive labor in the first stage should not prompt us to intervene. We should no longer apply the standards of active-phase progress – standards that have traditionally driven our diagnoses of labor dystocia – until the patient has achieved 6 cm of dilation.
The labor curve that had shaped our thinking about normal and abnormal labor progress until recently was developed by Dr. Emanuel Friedman. Based on findings from a prospective cohort study of 500 nulliparous women, Dr. Friedman plotted labor progress with centimeters of cervical dilation on the Y-axis and time on the X-axis, and divided labor into several stages and phases. In this curve, the rate of change of cervical dilation over time started increasing significantly at 4 cm; this period of increasing slope defined the active phase of labor.
Abnormal labor progress in the active phase was then defined, based on the 95th percentile, as cervical dilation of less than 1.2 cm per hour for nulliparous women and less than 1.5 cm per hour for multiparous women. Based on Dr. Friedman’s work, a woman was deemed to be in active-phase arrest when she had no cervical changes for 2 hours or more while having adequate uterine contractions and cervical dilation of at least 4 cm. These concepts came to govern labor management.
The paradigm shifted when the Consortium on Safe Labor reported in 2010 on a retrospective cohort study of more than 62,000 women at 19 U.S. hospitals. The women had a singleton term gestation, spontaneous labor, vertex presentation, vaginal delivery, and a normal perinatal outcome. In their analysis of labor and delivery information, Dr. Jun Zhang of the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development and his colleagues accounted for the fact that the exact times of cervical change are unknown.
They used modern statistical methods and analytical tools that took into account the specific nature of cervical dilation data – that cervical measurements are interval-censored (we never know the exact time when a woman’s cervix changes) and that multiple exams of the cervix in the same patient are not independent (Obstet Gynecol. 2010 Dec;116[6]:1281-7).
The methodology used in the Consortium study accounted for both the interval-censored and repeated-measures nature of cervical dilation data. It thus addressed analytical flaws in the previous approach to labor data, which was purely descriptive of the exam findings and did not consider the nature of the data itself.
Under the new analysis and in the larger, contemporary population of patients, the period of increasing slope was found to occur most commonly after 6 cm, not 4 cm. The slowest 5% of nulliparous women had cervical dilation of 0.4 cm per hour (with the median at 1.9 cm per hour), compared with 1.2 cm per hour (with a median of 3.0 cm per hour) as in the Friedman data.
Dr. Zhang’s study showed us that labor may take more than 6 hours to progress from 4 to 5 cm dilation, and more than 3 hours to progress from 5 to 6 cm dilation – a rate of progress that is significantly slower than what Dr. Friedman had described. The new data showed us, moreover, that from 4 cm-6 cm dilation, nulliparous and multiparous women progressed similarly slowly. Beyond 6 cm, multiparous women dilated more rapidly, with a steeper acceleration phase than previously described.
A consensus statement published in 2014 by the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) on “Safe Prevention of the Primary Cesarean Delivery” encourages use of the Consortium data to revisit the definition of labor dystocia. While the data “do not directly address an optimal duration for the diagnosis of active-phase protraction or labor arrest, [they] do suggest that neither should be diagnosed before 6 cm dilation” (Obstet Gynecol. 2014 Mar;123[3]:693-711).
The ACOG-SMFM statement makes a series of recommendations for managing the first and second stages of labor, based not only on the Consortium data but on a broader literature review. It recommends that if mother and fetus appear well, cesarean delivery for active-phase arrest in the first stage of labor be reserved for women of at least 6 cm of dilation with ruptured membranes who fail to progress despite 4 hours of adequate uterine activity, or at least 6 hours of oxytocin administration with inadequate uterine activity and no cervical change.
Regarding the latent phase of labor, the statement says that most women with a prolonged latent phase ultimately will enter the active phase with expectant management. It advises that a prolonged latent phase (for example, greater than 20 hours in nulliparous women and greater than 14 hours in multiparous women) should not be an isolated indication for cesarean delivery.
The consensus statement also recognizes recent data showing that women who undergo labor induction have an even slower “normal” course of labor, particularly a longer latent phase, than women who labor spontaneously. A retrospective cohort study of more than 5,000 women, for instance, found that before 6 cm, women whose labor is induced can spend up to 10 hours to achieve each 1 cm of dilation (Obstet Gynecol. 2012 Jun;119[6]:1113-8).
As long as maternal and fetal status are reassuring, the statement says, cesarean deliveries for failed induction of labor in the latent phase can be avoided by allowing longer durations of the latent phase (up to 24 hours) and by requiring that oxytocin be administered for 12-18 hours after membrane rupture before deeming induction a failure.
Each of these described recommendations were graded in the ACOG-SMFM consensus document as “strong” recommendations with “moderate quality evidence.”
Examining our standards
Moving forward, we must further develop and define our thresholds for identifying who will most benefit from a cesarean delivery. We have many specific aspects of labor management to address as well, such as the optimal timing of artificial membrane rupture and the safety and efficacy of different oxytocin protocols. We may also want to revisit recommendations for serial cervical assessment, possibly adjusting the intervals given our understanding of the new labor curve.
Under the new labor paradigm, moreover, we must think not only about the clinical decisions we make at the bedside, but about the decisions we make early in the labor management process.
The timing of admission is one such decision. A statement published in 2012 on “Preventing the First Cesarean Delivery” by ACOG, SMFM, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development advises us to avoid admittance of women during the early latent phase of labor (Obstet Gynecol. 2012 Nov;120[5]:1181-93).
It may even be advisable that we consider admittance at higher cervical dilation. A study published this year shows that women admitted at less than 6 cm of dilation had an increased risk of cesarean delivery, compared with women admitted at higher cervical dilation (Am J Perinatol. 2016 Jan;33[2]:188-94). We have more to learn, but certainly, given what we know now about labor progress and the start of active labor, the timing of admission is an important factor to consider.
The second stage of labor, defined as the interval from complete cervical dilation through delivery of the fetus, presents many questions as well. There is a paucity of quality published data concerning what is normal, how long the stage should last, and how we should manage it. Historically, we have been taught to allow 2 hours of pushing for nulliparous women and 1 hour for multiparous women, when epidural anesthesia has not been administered, and to add an additional hour when epidural is used.
The 2014 ACOG-SMFM consensus statement recommends extending each of these limits by an hour, if maternal and fetal conditions permit, so that we allow at least 3 hours of pushing for nulliparous women and at least 2 hours for multiparous women before diagnosing arrest of labor in the second stage. Longer durations may be appropriate with the use of epidural anesthesia and on an individualized basis.
At this time, it is unclear whether there is any absolute maximum length of time beyond which all women in the second stage of labor should undergo cesarean delivery. We also still do not know the optimal technique for managing maternal pushing during the second stage. Should women with an epidural push right away or should they allow for a period of spontaneous descent? Many of the high-quality studies reported thus far that compare delayed and immediate pushing have limited applicability to current practice because they involved now-obsolete midpelvic forceps deliveries. A large multicenter randomized trial currently underway should provide us with some answers.
Dr. Cahill is an associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University School of Medicine in St. Louis. She reported having no relevant financial disclosures.
Rethinking the management of labor
Over the last 50 years, we have witnessed some incredible advancements that have vastly improved maternal and fetal outcomes, even in the face of the most complex obstetrical dilemmas. As our practice and the research continues to evolve, it is increasingly important that we carefully review our practice standards to ensure that every woman and her baby receives the most up-to-date medical care.
This month’s Master Class highlights a critical area of obstetrics where the convergence of technology, clinical observation, and research stimulated a change in practice guidelines: the use of the labor curve to monitor normal versus abnormal labor. Until quite recently, ob.gyns. had based labor criteria on the “Friedman Curve,” first established in the mid-1950s, and supported by other smaller and less comprehensive studies. This work was adopted by the American College of Obstetricians and Gynecologists.
For more than half a century, we used these parameters to determine if a woman had entered active-phase arrest, and to make the very important decision of whether to perform a cesarean section. However, work in the early 2000s strongly suggested that the old criteria no longer applied to the full course of labor in contemporary patients (Am J Obstet Gynecol. 2002 Oct;187[4]:824-8). A 2010 comprehensive study showed that we needed to consider a new approach to labor management (Am J Obstet Gynecol. 2010 Oct;203[4]:326.e1-326.e10).
It may seem incredible that it took such a long time to update our thinking about what constitutes normal versus abnormal labor progression. However, we must keep in mind that many studies supported the original labor curve, and advanced tools to assess fetal health during labor were just being developed. The first commercially available fetal heart rate monitor would not be produced until 1968, and debates about the utility of these devices would continue into the early 1990s.
Additionally, our patient population has changed. As we have discussed in previous columns, the incidence and severity of other chronic conditions, such as diabetes and obesity, has increased significantly and deeply impacted labor progression.
Just as technology has advanced and our patients’ needs have changed, so, too, must our practice standards. We have invited Dr. Alison G. Cahill, associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University, St. Louis, to discuss the importance and implications of the new labor curve.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
Over the last 50 years, we have witnessed some incredible advancements that have vastly improved maternal and fetal outcomes, even in the face of the most complex obstetrical dilemmas. As our practice and the research continues to evolve, it is increasingly important that we carefully review our practice standards to ensure that every woman and her baby receives the most up-to-date medical care.
This month’s Master Class highlights a critical area of obstetrics where the convergence of technology, clinical observation, and research stimulated a change in practice guidelines: the use of the labor curve to monitor normal versus abnormal labor. Until quite recently, ob.gyns. had based labor criteria on the “Friedman Curve,” first established in the mid-1950s, and supported by other smaller and less comprehensive studies. This work was adopted by the American College of Obstetricians and Gynecologists.
For more than half a century, we used these parameters to determine if a woman had entered active-phase arrest, and to make the very important decision of whether to perform a cesarean section. However, work in the early 2000s strongly suggested that the old criteria no longer applied to the full course of labor in contemporary patients (Am J Obstet Gynecol. 2002 Oct;187[4]:824-8). A 2010 comprehensive study showed that we needed to consider a new approach to labor management (Am J Obstet Gynecol. 2010 Oct;203[4]:326.e1-326.e10).
It may seem incredible that it took such a long time to update our thinking about what constitutes normal versus abnormal labor progression. However, we must keep in mind that many studies supported the original labor curve, and advanced tools to assess fetal health during labor were just being developed. The first commercially available fetal heart rate monitor would not be produced until 1968, and debates about the utility of these devices would continue into the early 1990s.
Additionally, our patient population has changed. As we have discussed in previous columns, the incidence and severity of other chronic conditions, such as diabetes and obesity, has increased significantly and deeply impacted labor progression.
Just as technology has advanced and our patients’ needs have changed, so, too, must our practice standards. We have invited Dr. Alison G. Cahill, associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University, St. Louis, to discuss the importance and implications of the new labor curve.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
Over the last 50 years, we have witnessed some incredible advancements that have vastly improved maternal and fetal outcomes, even in the face of the most complex obstetrical dilemmas. As our practice and the research continues to evolve, it is increasingly important that we carefully review our practice standards to ensure that every woman and her baby receives the most up-to-date medical care.
This month’s Master Class highlights a critical area of obstetrics where the convergence of technology, clinical observation, and research stimulated a change in practice guidelines: the use of the labor curve to monitor normal versus abnormal labor. Until quite recently, ob.gyns. had based labor criteria on the “Friedman Curve,” first established in the mid-1950s, and supported by other smaller and less comprehensive studies. This work was adopted by the American College of Obstetricians and Gynecologists.
For more than half a century, we used these parameters to determine if a woman had entered active-phase arrest, and to make the very important decision of whether to perform a cesarean section. However, work in the early 2000s strongly suggested that the old criteria no longer applied to the full course of labor in contemporary patients (Am J Obstet Gynecol. 2002 Oct;187[4]:824-8). A 2010 comprehensive study showed that we needed to consider a new approach to labor management (Am J Obstet Gynecol. 2010 Oct;203[4]:326.e1-326.e10).
It may seem incredible that it took such a long time to update our thinking about what constitutes normal versus abnormal labor progression. However, we must keep in mind that many studies supported the original labor curve, and advanced tools to assess fetal health during labor were just being developed. The first commercially available fetal heart rate monitor would not be produced until 1968, and debates about the utility of these devices would continue into the early 1990s.
Additionally, our patient population has changed. As we have discussed in previous columns, the incidence and severity of other chronic conditions, such as diabetes and obesity, has increased significantly and deeply impacted labor progression.
Just as technology has advanced and our patients’ needs have changed, so, too, must our practice standards. We have invited Dr. Alison G. Cahill, associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University, St. Louis, to discuss the importance and implications of the new labor curve.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
Infection control is everyone’s responsibility
Big things come in small packages, very small – so small they may even be invisible to the naked eye. Take for instance a huge infection causing multiorgan system failure, disseminated intravascular coagulation, even septic shock refractory to high-dose pressors. This catastrophe may be the end result of exposure to tiny pathogenic microbes that can take down an otherwise healthy 300-pound man, tout suite!
Microorganisms are everywhere. We can’t live without them, but we can’t live with certain ones either. Unless you live in a bubble you are going to be exposed to countless bacteria each and every day. They are in the air we breathe, the water we drink, the beds we sleep in. While it is a given that we all will be continuously exposed to bacteria, having a well-considered strategy to curtail the spread of disease can dramatically decrease the risk that we, our families, and our patients are needlessly exposed to potentially life-threatening organisms.
We all know we are to wash our hands on the way in, and out, of patients’ rooms. This practice is our front line of defense against the spread of numerous potentially lethal diseases. Yet, many clinicians, as well as ancillary hospital personnel, repeatedly fail to abide by this rule, thinking that ‘this one time won’t hurt anything.’ Whether it’s the nurse who rushes into a patient’s room to stop a beeping IV pole or the doctor who eyes a family member in the room and makes a beeline to discuss the discharge plan, all of us have been guilty of entering or leaving a patient’s room without following appropriate infection control standards.
Or, how many times have you followed the protocol meticulously, at least initially, and removed your gown and gloves and washed your hands on your way out the door when the patient remembers another question, or asks you to hand him something that leads to more contact with him or his surroundings? You already washed your hands once, so must you really do it again? After all, what is the likelihood that you pick up (or pass along) any germs anyway? Sometimes, more than we realize. Something as simple as handing a patient his nurses’ call button can expose us to enough C. difficile spores to cause infection in us or others we come into contact with unwittingly. So wash those hands, and wash them again if you touch anything in a patient’s room, even if it is not the patient himself.
Direct observation (AKA “Secret Santas”) can provide invaluable information about adherence to hand hygiene among health care workers and providing feedback is key. This can be unit based, group based, and even provider based. Once collected, this information should be used to drive changes in behavior, which could be punitive or positive; each hospital should decide how to best use its data.
Visitor contact is another important issue and not everyone agrees on how to enforce, or whether to even try to enforce, infection control procedures. The Society for Healthcare Epidemiology of America (SHEA) has several helpful pocket guidelines to address this and other infection control issues. For instance, the society recommends that hospitals consider adopting guidelines to minimize horizontal transmission by visitors, though these guidelines should be feasible to enforce. Factors such as the specific organism and its potential to cause harm are important to consider when developing these guidelines. For instance, the spouse of a patient admitted with influenza has likely already been exposed, and postexposure prophylaxis may be more feasible to her than wearing an uncomfortable mask during an 8-hour hospital visit.
A pharmacy stewardship program is another invaluable infection control tool. With this model, a group of pharmacists, under the direction of an infectious disease specialist, reviews culture results daily and makes recommendations to the physician regarding narrowing antibiotic coverage. I greatly appreciate receiving calls to notify me that the final culture results are in long before I would have actually seen them myself. This allows me to adjust antibiotics in a timely fashion, thus reducing the emergence of drug-resistant organisms or precipitating an unnecessary case of C. difficile.
In addition, written guidelines should be established for indwelling catheters, both urinary and venous. The indication for continued use should be reassessed daily; a computer alert that requires a response is very helpful, as is a call from the friendly floor nurse asking, “Does this patient really still need his catheter?”
Infection control is everyone’s responsibility and we all need to work together toward this common goal.
Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].
Big things come in small packages, very small – so small they may even be invisible to the naked eye. Take for instance a huge infection causing multiorgan system failure, disseminated intravascular coagulation, even septic shock refractory to high-dose pressors. This catastrophe may be the end result of exposure to tiny pathogenic microbes that can take down an otherwise healthy 300-pound man, tout suite!
Microorganisms are everywhere. We can’t live without them, but we can’t live with certain ones either. Unless you live in a bubble you are going to be exposed to countless bacteria each and every day. They are in the air we breathe, the water we drink, the beds we sleep in. While it is a given that we all will be continuously exposed to bacteria, having a well-considered strategy to curtail the spread of disease can dramatically decrease the risk that we, our families, and our patients are needlessly exposed to potentially life-threatening organisms.
We all know we are to wash our hands on the way in, and out, of patients’ rooms. This practice is our front line of defense against the spread of numerous potentially lethal diseases. Yet, many clinicians, as well as ancillary hospital personnel, repeatedly fail to abide by this rule, thinking that ‘this one time won’t hurt anything.’ Whether it’s the nurse who rushes into a patient’s room to stop a beeping IV pole or the doctor who eyes a family member in the room and makes a beeline to discuss the discharge plan, all of us have been guilty of entering or leaving a patient’s room without following appropriate infection control standards.
Or, how many times have you followed the protocol meticulously, at least initially, and removed your gown and gloves and washed your hands on your way out the door when the patient remembers another question, or asks you to hand him something that leads to more contact with him or his surroundings? You already washed your hands once, so must you really do it again? After all, what is the likelihood that you pick up (or pass along) any germs anyway? Sometimes, more than we realize. Something as simple as handing a patient his nurses’ call button can expose us to enough C. difficile spores to cause infection in us or others we come into contact with unwittingly. So wash those hands, and wash them again if you touch anything in a patient’s room, even if it is not the patient himself.
Direct observation (AKA “Secret Santas”) can provide invaluable information about adherence to hand hygiene among health care workers and providing feedback is key. This can be unit based, group based, and even provider based. Once collected, this information should be used to drive changes in behavior, which could be punitive or positive; each hospital should decide how to best use its data.
Visitor contact is another important issue and not everyone agrees on how to enforce, or whether to even try to enforce, infection control procedures. The Society for Healthcare Epidemiology of America (SHEA) has several helpful pocket guidelines to address this and other infection control issues. For instance, the society recommends that hospitals consider adopting guidelines to minimize horizontal transmission by visitors, though these guidelines should be feasible to enforce. Factors such as the specific organism and its potential to cause harm are important to consider when developing these guidelines. For instance, the spouse of a patient admitted with influenza has likely already been exposed, and postexposure prophylaxis may be more feasible to her than wearing an uncomfortable mask during an 8-hour hospital visit.
A pharmacy stewardship program is another invaluable infection control tool. With this model, a group of pharmacists, under the direction of an infectious disease specialist, reviews culture results daily and makes recommendations to the physician regarding narrowing antibiotic coverage. I greatly appreciate receiving calls to notify me that the final culture results are in long before I would have actually seen them myself. This allows me to adjust antibiotics in a timely fashion, thus reducing the emergence of drug-resistant organisms or precipitating an unnecessary case of C. difficile.
In addition, written guidelines should be established for indwelling catheters, both urinary and venous. The indication for continued use should be reassessed daily; a computer alert that requires a response is very helpful, as is a call from the friendly floor nurse asking, “Does this patient really still need his catheter?”
Infection control is everyone’s responsibility and we all need to work together toward this common goal.
Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].
Big things come in small packages, very small – so small they may even be invisible to the naked eye. Take for instance a huge infection causing multiorgan system failure, disseminated intravascular coagulation, even septic shock refractory to high-dose pressors. This catastrophe may be the end result of exposure to tiny pathogenic microbes that can take down an otherwise healthy 300-pound man, tout suite!
Microorganisms are everywhere. We can’t live without them, but we can’t live with certain ones either. Unless you live in a bubble you are going to be exposed to countless bacteria each and every day. They are in the air we breathe, the water we drink, the beds we sleep in. While it is a given that we all will be continuously exposed to bacteria, having a well-considered strategy to curtail the spread of disease can dramatically decrease the risk that we, our families, and our patients are needlessly exposed to potentially life-threatening organisms.
We all know we are to wash our hands on the way in, and out, of patients’ rooms. This practice is our front line of defense against the spread of numerous potentially lethal diseases. Yet, many clinicians, as well as ancillary hospital personnel, repeatedly fail to abide by this rule, thinking that ‘this one time won’t hurt anything.’ Whether it’s the nurse who rushes into a patient’s room to stop a beeping IV pole or the doctor who eyes a family member in the room and makes a beeline to discuss the discharge plan, all of us have been guilty of entering or leaving a patient’s room without following appropriate infection control standards.
Or, how many times have you followed the protocol meticulously, at least initially, and removed your gown and gloves and washed your hands on your way out the door when the patient remembers another question, or asks you to hand him something that leads to more contact with him or his surroundings? You already washed your hands once, so must you really do it again? After all, what is the likelihood that you pick up (or pass along) any germs anyway? Sometimes, more than we realize. Something as simple as handing a patient his nurses’ call button can expose us to enough C. difficile spores to cause infection in us or others we come into contact with unwittingly. So wash those hands, and wash them again if you touch anything in a patient’s room, even if it is not the patient himself.
Direct observation (AKA “Secret Santas”) can provide invaluable information about adherence to hand hygiene among health care workers and providing feedback is key. This can be unit based, group based, and even provider based. Once collected, this information should be used to drive changes in behavior, which could be punitive or positive; each hospital should decide how to best use its data.
Visitor contact is another important issue and not everyone agrees on how to enforce, or whether to even try to enforce, infection control procedures. The Society for Healthcare Epidemiology of America (SHEA) has several helpful pocket guidelines to address this and other infection control issues. For instance, the society recommends that hospitals consider adopting guidelines to minimize horizontal transmission by visitors, though these guidelines should be feasible to enforce. Factors such as the specific organism and its potential to cause harm are important to consider when developing these guidelines. For instance, the spouse of a patient admitted with influenza has likely already been exposed, and postexposure prophylaxis may be more feasible to her than wearing an uncomfortable mask during an 8-hour hospital visit.
A pharmacy stewardship program is another invaluable infection control tool. With this model, a group of pharmacists, under the direction of an infectious disease specialist, reviews culture results daily and makes recommendations to the physician regarding narrowing antibiotic coverage. I greatly appreciate receiving calls to notify me that the final culture results are in long before I would have actually seen them myself. This allows me to adjust antibiotics in a timely fashion, thus reducing the emergence of drug-resistant organisms or precipitating an unnecessary case of C. difficile.
In addition, written guidelines should be established for indwelling catheters, both urinary and venous. The indication for continued use should be reassessed daily; a computer alert that requires a response is very helpful, as is a call from the friendly floor nurse asking, “Does this patient really still need his catheter?”
Infection control is everyone’s responsibility and we all need to work together toward this common goal.
Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].
Sorrows hidden in plain sight
“The greatest hazard of all, losing one’s self, can occur very quietly in the world, as if it were nothing at all. No other loss can occur so quietly”
—Søren Kierkegaard
In our interactions with patients we often focus on the medical issue at hand, forgetting the other dimensions of our patients’ lives. Yet these invisible dimensions can have a huge impact on their humanity. I humbly submit that it can be profoundly meaningful, for them and for us, if we paid close attention.
1. JV has rheumatoid arthritis. He is not the most compliant, and I had not seen him in over a year. He was well controlled on Enbrel.
He came to the office one day last week to make an appointment. We gave him one for the next day, but he missed the appointment. When he finally came a week later, I got the real story. He had gotten arrested.
The day he came into my office to ask for an appointment after a prolonged absence, it was because his insurance was denying coverage for his Enbrel. His next stop, after making his appointment, was to the Social Security office to try to sort out his coverage. When asked about whether or not he needed special accommodations, he made a point to mention his hearing loss. However, the person ultimately assigned to help him was not a native English speaker. This made for a very confusing and loud exchange that led to a heated argument with security. It ended with him being led out of the office in handcuffs, and spending the night in jail.
2. Tyler has inflammatory arthritis. He received his diagnosis in Arizona 5 years ago. He was stable on Plaquenil when I met him a year ago, and I only see him every 6 months.
On our third visit, I noticed he had gained weight. He attributed this to the discontinuation of his Dexedrine, in the interest of adjusting his medications for bipolar disorder. I couldn’t remember our second visit very well, but he apologized profusely for having been “lit.” He apparently was so manic that it drove his family crazy. In an effort to get him to take medications for the problem, his sister said: “It’s like living with Vincent van Gogh, except now we have meds for it.”
Now he takes his medications. As a result, his body feels foreign. In the summer, he ran around the backyard all day and night constructing an obstacle course for his dog that he knew he would never get right. Now he is lucky if he gets a few days a week of productive work on his art. He feels dulled; he is not as quick-witted. It is sad, but, he says, this is what society expects of him.
3. Judy is in her mid-70s. That’s not old these days, but she is somewhat crippled by her rheumatoid arthritis. She lived in Manhattan with her husband and enjoyed the city immensely. After her husband passed away, she managed to live in her Manhattan apartment independently for a little bit, but after suffering a fall, she let her children move her to Rhode Island to be closer to them. She has struggled to find her own apartment with amenities that will allow her to remain independent. For the past 3 years she has been in an assisted living facility.
She is so unhappy there. She doesn’t like forced interactions, doesn’t like to gossip, doesn’t like when her neighbors behave like they’re in middle school. It has taken 3 years for the people around her to finally respect her desire to be left alone, to spend her time reading and listening to the opera rather than engaging in idle chitchat that does not interest her at all.
Dr. Chan practices rheumatology in Pawtucket, R.I.
“The greatest hazard of all, losing one’s self, can occur very quietly in the world, as if it were nothing at all. No other loss can occur so quietly”
—Søren Kierkegaard
In our interactions with patients we often focus on the medical issue at hand, forgetting the other dimensions of our patients’ lives. Yet these invisible dimensions can have a huge impact on their humanity. I humbly submit that it can be profoundly meaningful, for them and for us, if we paid close attention.
1. JV has rheumatoid arthritis. He is not the most compliant, and I had not seen him in over a year. He was well controlled on Enbrel.
He came to the office one day last week to make an appointment. We gave him one for the next day, but he missed the appointment. When he finally came a week later, I got the real story. He had gotten arrested.
The day he came into my office to ask for an appointment after a prolonged absence, it was because his insurance was denying coverage for his Enbrel. His next stop, after making his appointment, was to the Social Security office to try to sort out his coverage. When asked about whether or not he needed special accommodations, he made a point to mention his hearing loss. However, the person ultimately assigned to help him was not a native English speaker. This made for a very confusing and loud exchange that led to a heated argument with security. It ended with him being led out of the office in handcuffs, and spending the night in jail.
2. Tyler has inflammatory arthritis. He received his diagnosis in Arizona 5 years ago. He was stable on Plaquenil when I met him a year ago, and I only see him every 6 months.
On our third visit, I noticed he had gained weight. He attributed this to the discontinuation of his Dexedrine, in the interest of adjusting his medications for bipolar disorder. I couldn’t remember our second visit very well, but he apologized profusely for having been “lit.” He apparently was so manic that it drove his family crazy. In an effort to get him to take medications for the problem, his sister said: “It’s like living with Vincent van Gogh, except now we have meds for it.”
Now he takes his medications. As a result, his body feels foreign. In the summer, he ran around the backyard all day and night constructing an obstacle course for his dog that he knew he would never get right. Now he is lucky if he gets a few days a week of productive work on his art. He feels dulled; he is not as quick-witted. It is sad, but, he says, this is what society expects of him.
3. Judy is in her mid-70s. That’s not old these days, but she is somewhat crippled by her rheumatoid arthritis. She lived in Manhattan with her husband and enjoyed the city immensely. After her husband passed away, she managed to live in her Manhattan apartment independently for a little bit, but after suffering a fall, she let her children move her to Rhode Island to be closer to them. She has struggled to find her own apartment with amenities that will allow her to remain independent. For the past 3 years she has been in an assisted living facility.
She is so unhappy there. She doesn’t like forced interactions, doesn’t like to gossip, doesn’t like when her neighbors behave like they’re in middle school. It has taken 3 years for the people around her to finally respect her desire to be left alone, to spend her time reading and listening to the opera rather than engaging in idle chitchat that does not interest her at all.
Dr. Chan practices rheumatology in Pawtucket, R.I.
“The greatest hazard of all, losing one’s self, can occur very quietly in the world, as if it were nothing at all. No other loss can occur so quietly”
—Søren Kierkegaard
In our interactions with patients we often focus on the medical issue at hand, forgetting the other dimensions of our patients’ lives. Yet these invisible dimensions can have a huge impact on their humanity. I humbly submit that it can be profoundly meaningful, for them and for us, if we paid close attention.
1. JV has rheumatoid arthritis. He is not the most compliant, and I had not seen him in over a year. He was well controlled on Enbrel.
He came to the office one day last week to make an appointment. We gave him one for the next day, but he missed the appointment. When he finally came a week later, I got the real story. He had gotten arrested.
The day he came into my office to ask for an appointment after a prolonged absence, it was because his insurance was denying coverage for his Enbrel. His next stop, after making his appointment, was to the Social Security office to try to sort out his coverage. When asked about whether or not he needed special accommodations, he made a point to mention his hearing loss. However, the person ultimately assigned to help him was not a native English speaker. This made for a very confusing and loud exchange that led to a heated argument with security. It ended with him being led out of the office in handcuffs, and spending the night in jail.
2. Tyler has inflammatory arthritis. He received his diagnosis in Arizona 5 years ago. He was stable on Plaquenil when I met him a year ago, and I only see him every 6 months.
On our third visit, I noticed he had gained weight. He attributed this to the discontinuation of his Dexedrine, in the interest of adjusting his medications for bipolar disorder. I couldn’t remember our second visit very well, but he apologized profusely for having been “lit.” He apparently was so manic that it drove his family crazy. In an effort to get him to take medications for the problem, his sister said: “It’s like living with Vincent van Gogh, except now we have meds for it.”
Now he takes his medications. As a result, his body feels foreign. In the summer, he ran around the backyard all day and night constructing an obstacle course for his dog that he knew he would never get right. Now he is lucky if he gets a few days a week of productive work on his art. He feels dulled; he is not as quick-witted. It is sad, but, he says, this is what society expects of him.
3. Judy is in her mid-70s. That’s not old these days, but she is somewhat crippled by her rheumatoid arthritis. She lived in Manhattan with her husband and enjoyed the city immensely. After her husband passed away, she managed to live in her Manhattan apartment independently for a little bit, but after suffering a fall, she let her children move her to Rhode Island to be closer to them. She has struggled to find her own apartment with amenities that will allow her to remain independent. For the past 3 years she has been in an assisted living facility.
She is so unhappy there. She doesn’t like forced interactions, doesn’t like to gossip, doesn’t like when her neighbors behave like they’re in middle school. It has taken 3 years for the people around her to finally respect her desire to be left alone, to spend her time reading and listening to the opera rather than engaging in idle chitchat that does not interest her at all.
Dr. Chan practices rheumatology in Pawtucket, R.I.
#payattention
Social media consumes the attention of the majority of teens. It is a place to express yourself, flirt, intimidate, and keep them up to date with the latest happenings in the social circles. But, teens are using social media for much more.
Instagram, a social media site comprising photographs followed by comments, is one of the most common sites used by teens. They post everything from the meal they are eating to the new love in their life and everything in between.
A hashtag is a type of label or metadata tag used on social networks and microblogging services, which makes it easier for users to find messages with a specific theme or content. Users create hashtags by placing the hash character # (the number sign) in front of a word or unspaced phrase, either in the main text of a message or at the end. Searching for that hashtag will then present each message that has been tagged with it.1 Although teens seem to prefer simple phrases, these hashtags are used to link users to what many refer to as “Secret Society.”
For example, if a teen girl was “cutting” or interested in connecting with other teens that cut, putting #cat would link her to several social communities with the related topic. Similarly, #selfharm was the initial term used to connect to this secret society. When that was shut down by the social media site, it resurfaced as #selfharmmm2.
#MySecretFamily is a very popular hashtag that connects teens struggling with a variety of mental illnesses. Teens are instructed to put various names in their profile to identify which mental illness they are battling. For example, depression would be identified as “DEB” for a girl and “DAN” for a boy. The chart below lists various disorders.2
Nonsuicidal self-injury (NSSI) or deliberate destruction of one’s body in the absence of suicidal intent3 is most common in the middle school ages, and exposure to peer NSSI may increase the risk of engaging these behaviors.2,4 Although distinct from suicidal behaviors, there is a comorbidity between them. The normalization of these behaviors through social media and acceptance into the this “Secret Society” can only augment the risk of NSSI.
Parents not only need to be educated about the importance of monitoring their children’s social media but also about what to look for that may be a sign that something more serious is going on with them.
Although we hear so much of the negative impact of social media, it also can be a tool for early intervention.
References
1. Oxford English Dictionary, definition of “hashtag.”
2. J Adolesc Health. 2016 Jan;58(1):78-84.
4. Dev Psychol. 2006 May;42(3):407-17.
Dr. Pearce is a pediatrician in Frankfort, Ill. Email her at [email protected].
Social media consumes the attention of the majority of teens. It is a place to express yourself, flirt, intimidate, and keep them up to date with the latest happenings in the social circles. But, teens are using social media for much more.
Instagram, a social media site comprising photographs followed by comments, is one of the most common sites used by teens. They post everything from the meal they are eating to the new love in their life and everything in between.
A hashtag is a type of label or metadata tag used on social networks and microblogging services, which makes it easier for users to find messages with a specific theme or content. Users create hashtags by placing the hash character # (the number sign) in front of a word or unspaced phrase, either in the main text of a message or at the end. Searching for that hashtag will then present each message that has been tagged with it.1 Although teens seem to prefer simple phrases, these hashtags are used to link users to what many refer to as “Secret Society.”
For example, if a teen girl was “cutting” or interested in connecting with other teens that cut, putting #cat would link her to several social communities with the related topic. Similarly, #selfharm was the initial term used to connect to this secret society. When that was shut down by the social media site, it resurfaced as #selfharmmm2.
#MySecretFamily is a very popular hashtag that connects teens struggling with a variety of mental illnesses. Teens are instructed to put various names in their profile to identify which mental illness they are battling. For example, depression would be identified as “DEB” for a girl and “DAN” for a boy. The chart below lists various disorders.2
Nonsuicidal self-injury (NSSI) or deliberate destruction of one’s body in the absence of suicidal intent3 is most common in the middle school ages, and exposure to peer NSSI may increase the risk of engaging these behaviors.2,4 Although distinct from suicidal behaviors, there is a comorbidity between them. The normalization of these behaviors through social media and acceptance into the this “Secret Society” can only augment the risk of NSSI.
Parents not only need to be educated about the importance of monitoring their children’s social media but also about what to look for that may be a sign that something more serious is going on with them.
Although we hear so much of the negative impact of social media, it also can be a tool for early intervention.
References
1. Oxford English Dictionary, definition of “hashtag.”
2. J Adolesc Health. 2016 Jan;58(1):78-84.
4. Dev Psychol. 2006 May;42(3):407-17.
Dr. Pearce is a pediatrician in Frankfort, Ill. Email her at [email protected].
Social media consumes the attention of the majority of teens. It is a place to express yourself, flirt, intimidate, and keep them up to date with the latest happenings in the social circles. But, teens are using social media for much more.
Instagram, a social media site comprising photographs followed by comments, is one of the most common sites used by teens. They post everything from the meal they are eating to the new love in their life and everything in between.
A hashtag is a type of label or metadata tag used on social networks and microblogging services, which makes it easier for users to find messages with a specific theme or content. Users create hashtags by placing the hash character # (the number sign) in front of a word or unspaced phrase, either in the main text of a message or at the end. Searching for that hashtag will then present each message that has been tagged with it.1 Although teens seem to prefer simple phrases, these hashtags are used to link users to what many refer to as “Secret Society.”
For example, if a teen girl was “cutting” or interested in connecting with other teens that cut, putting #cat would link her to several social communities with the related topic. Similarly, #selfharm was the initial term used to connect to this secret society. When that was shut down by the social media site, it resurfaced as #selfharmmm2.
#MySecretFamily is a very popular hashtag that connects teens struggling with a variety of mental illnesses. Teens are instructed to put various names in their profile to identify which mental illness they are battling. For example, depression would be identified as “DEB” for a girl and “DAN” for a boy. The chart below lists various disorders.2
Nonsuicidal self-injury (NSSI) or deliberate destruction of one’s body in the absence of suicidal intent3 is most common in the middle school ages, and exposure to peer NSSI may increase the risk of engaging these behaviors.2,4 Although distinct from suicidal behaviors, there is a comorbidity between them. The normalization of these behaviors through social media and acceptance into the this “Secret Society” can only augment the risk of NSSI.
Parents not only need to be educated about the importance of monitoring their children’s social media but also about what to look for that may be a sign that something more serious is going on with them.
Although we hear so much of the negative impact of social media, it also can be a tool for early intervention.
References
1. Oxford English Dictionary, definition of “hashtag.”
2. J Adolesc Health. 2016 Jan;58(1):78-84.
4. Dev Psychol. 2006 May;42(3):407-17.
Dr. Pearce is a pediatrician in Frankfort, Ill. Email her at [email protected].
Treating influenza: A guide to antiviral safety in pregnancy
Oseltamivir and zanamivir are competitive inhibitors for the neuraminidase enzyme for the influenza virus. They block the surface receptor enzyme and prevent release of virus from the host cell, thus limiting propagation of the infection. These medications can be given as prophylaxis after exposure to influenza or can be given therapeutically for a suspected or confirmed infection. Oseltamivir is recommended for treatment of suspected or confirmed influenza infection in the special population of pregnant women, as the risk for complications of influenza is increased in this group.
Safety evidence
However, there are limited data on the safety and efficacy of the neuraminidase inhibitors in pregnancy. With respect to safety, there have been seven publications in the literature addressing the risk for major birth defects following treatment or prophylaxis with one or both of these products, with the majority of the published data relating to oseltamivir exposure.
In a review by Tanaka et al. in 2009, 90 pregnancies treated therapeutically with oseltamivir in the first trimester were reported to two teratogen information services in Japan; one major birth defect (1.1%) was reported (CMAJ. 2009 Jul 7;181[1-2]:55-8). A year later, Greer et al. published a retrospective chart review at a Texas hospital between 2003 and 2008. During that period, 137 pregnancies that involved a pharmacy record of dispensing of oseltamivir were identified. Of these, 18 were dispensed in the first trimester, and none were linked to a major birth defect outcome (Obstet Gynecol. 2010 Apr;115[4]:711-6).
A 2011 record linkage study in Sweden identified 86 pregnant women for whom oseltamivir (n=81) or zanamivir had been prescribed. Of these, four were linked to a major birth defect in the infant; however, only one of the four prescriptions had been filled in the first trimester (Pharmacoepidemiol Drug Saf. 2011 Oct;20[10]:1030-4). In 2013, Saito et al. reported on a case series gathered from 157 obstetric facilities in Japan. Among 156 infants born to women exposed to oseltamivir in the first trimester, 2 (1.3%) were reported to have a major congenital anomaly; there were no congenital malformations reported in the 15 first-trimester exposures to zanamivir (Am J Obstet Gynecol. 2013 Aug;209[2[:130.e1-9).
In 2014, a teratogen information service in the United Kingdom reported on eight first-trimester exposures to oseltamivir and 37 to zanamivir, with no major birth defects noted in either group (BJOG. 2014 Jun;121[7]:901-6). Additionally, a French prescription database study identified 49 pregnancies thought to be exposed to oseltamivir in the first trimester with one reported congenital anomaly (BJOG. 2014 Jun;121[7]:895-900).
Finally, the manufacturer of oseltamivir published a summary of pregnancies from global pharmacovigilance data accumulated through spontaneous reports and other studies between 2000 and 2012 (Pharmacoepidemiol Drug Saf. 2014 Oct;23[10]:1035-42). Outcomes were available for 1,875 infants. Among these, 81 (4.3%) had major birth defects. However, following case review, the authors indicated that only 11 of the defects (occurring in 9 infants) were biologically plausible based on the timing of the exposure to oseltamivir.
Efficacy examined
With respect to efficacy, two small studies have addressed the pharmacokinetics of oseltamivir in pregnancy to determine if the recommended dosages for nonpregnant individuals are appropriate for pregnancy.
In the earlier of the two studies, Greer et al. looked at the pharmacokinetics of oseltamivir in 30 pregnant women, 10 in each of the three trimesters, who were taking 75 mg of the drug either once or twice daily. Maternal samples were drawn before and after the first dose of oseltamivir. They found little evidence of differences across the three trimesters and concluded that the parent drug values were in the pharmacologic range for clinical efficacy (Am J Obstet Gynecol. 2011 Jun;204[6 Suppl 1]:S89-93).
In contrast, Pillai et al. enrolled a small sample of women being treated with oseltamivir; they evaluated pharmacokinetics for the active metabolite of oseltamivir following 48 or more hours of treatment in 29 pregnant and 35 nonpregnant women (Br J Clin Pharmacol. 2015 Nov;80[5]:1042-50). Significantly lower levels of the active metabolite were noted in the pregnant women, compared with nonpregnant women. The authors suggested that the physiologic changes of pregnancy, correlated with increased renal clearance, produced an approximate 30% lower exposure to the drug in the pregnant state. While they were not able to relate this to maternal or infant outcomes, this finding suggested that further work is needed to determine if dosing recommendations should be adjusted in pregnancy.
The current recommendation is that pregnant women or women within 2 weeks post partum be given oseltamivir for treatment of suspected or confirmed influenza regardless of trimester of pregnancy. The limited safety data that are currently available have not suggested an increased risk for major birth defects following treatment with this product. However, the data are sparse for oseltamivir and even more so for zanamivir. Larger studies focused on these treatments are needed.
Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She reported having no financial disclosures relevant to this column, but has received research funding Roche-Genentech and GlaxoSmithKline unrelated to antiviral medications. Email her at [email protected].
Oseltamivir and zanamivir are competitive inhibitors for the neuraminidase enzyme for the influenza virus. They block the surface receptor enzyme and prevent release of virus from the host cell, thus limiting propagation of the infection. These medications can be given as prophylaxis after exposure to influenza or can be given therapeutically for a suspected or confirmed infection. Oseltamivir is recommended for treatment of suspected or confirmed influenza infection in the special population of pregnant women, as the risk for complications of influenza is increased in this group.
Safety evidence
However, there are limited data on the safety and efficacy of the neuraminidase inhibitors in pregnancy. With respect to safety, there have been seven publications in the literature addressing the risk for major birth defects following treatment or prophylaxis with one or both of these products, with the majority of the published data relating to oseltamivir exposure.
In a review by Tanaka et al. in 2009, 90 pregnancies treated therapeutically with oseltamivir in the first trimester were reported to two teratogen information services in Japan; one major birth defect (1.1%) was reported (CMAJ. 2009 Jul 7;181[1-2]:55-8). A year later, Greer et al. published a retrospective chart review at a Texas hospital between 2003 and 2008. During that period, 137 pregnancies that involved a pharmacy record of dispensing of oseltamivir were identified. Of these, 18 were dispensed in the first trimester, and none were linked to a major birth defect outcome (Obstet Gynecol. 2010 Apr;115[4]:711-6).
A 2011 record linkage study in Sweden identified 86 pregnant women for whom oseltamivir (n=81) or zanamivir had been prescribed. Of these, four were linked to a major birth defect in the infant; however, only one of the four prescriptions had been filled in the first trimester (Pharmacoepidemiol Drug Saf. 2011 Oct;20[10]:1030-4). In 2013, Saito et al. reported on a case series gathered from 157 obstetric facilities in Japan. Among 156 infants born to women exposed to oseltamivir in the first trimester, 2 (1.3%) were reported to have a major congenital anomaly; there were no congenital malformations reported in the 15 first-trimester exposures to zanamivir (Am J Obstet Gynecol. 2013 Aug;209[2[:130.e1-9).
In 2014, a teratogen information service in the United Kingdom reported on eight first-trimester exposures to oseltamivir and 37 to zanamivir, with no major birth defects noted in either group (BJOG. 2014 Jun;121[7]:901-6). Additionally, a French prescription database study identified 49 pregnancies thought to be exposed to oseltamivir in the first trimester with one reported congenital anomaly (BJOG. 2014 Jun;121[7]:895-900).
Finally, the manufacturer of oseltamivir published a summary of pregnancies from global pharmacovigilance data accumulated through spontaneous reports and other studies between 2000 and 2012 (Pharmacoepidemiol Drug Saf. 2014 Oct;23[10]:1035-42). Outcomes were available for 1,875 infants. Among these, 81 (4.3%) had major birth defects. However, following case review, the authors indicated that only 11 of the defects (occurring in 9 infants) were biologically plausible based on the timing of the exposure to oseltamivir.
Efficacy examined
With respect to efficacy, two small studies have addressed the pharmacokinetics of oseltamivir in pregnancy to determine if the recommended dosages for nonpregnant individuals are appropriate for pregnancy.
In the earlier of the two studies, Greer et al. looked at the pharmacokinetics of oseltamivir in 30 pregnant women, 10 in each of the three trimesters, who were taking 75 mg of the drug either once or twice daily. Maternal samples were drawn before and after the first dose of oseltamivir. They found little evidence of differences across the three trimesters and concluded that the parent drug values were in the pharmacologic range for clinical efficacy (Am J Obstet Gynecol. 2011 Jun;204[6 Suppl 1]:S89-93).
In contrast, Pillai et al. enrolled a small sample of women being treated with oseltamivir; they evaluated pharmacokinetics for the active metabolite of oseltamivir following 48 or more hours of treatment in 29 pregnant and 35 nonpregnant women (Br J Clin Pharmacol. 2015 Nov;80[5]:1042-50). Significantly lower levels of the active metabolite were noted in the pregnant women, compared with nonpregnant women. The authors suggested that the physiologic changes of pregnancy, correlated with increased renal clearance, produced an approximate 30% lower exposure to the drug in the pregnant state. While they were not able to relate this to maternal or infant outcomes, this finding suggested that further work is needed to determine if dosing recommendations should be adjusted in pregnancy.
The current recommendation is that pregnant women or women within 2 weeks post partum be given oseltamivir for treatment of suspected or confirmed influenza regardless of trimester of pregnancy. The limited safety data that are currently available have not suggested an increased risk for major birth defects following treatment with this product. However, the data are sparse for oseltamivir and even more so for zanamivir. Larger studies focused on these treatments are needed.
Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She reported having no financial disclosures relevant to this column, but has received research funding Roche-Genentech and GlaxoSmithKline unrelated to antiviral medications. Email her at [email protected].
Oseltamivir and zanamivir are competitive inhibitors for the neuraminidase enzyme for the influenza virus. They block the surface receptor enzyme and prevent release of virus from the host cell, thus limiting propagation of the infection. These medications can be given as prophylaxis after exposure to influenza or can be given therapeutically for a suspected or confirmed infection. Oseltamivir is recommended for treatment of suspected or confirmed influenza infection in the special population of pregnant women, as the risk for complications of influenza is increased in this group.
Safety evidence
However, there are limited data on the safety and efficacy of the neuraminidase inhibitors in pregnancy. With respect to safety, there have been seven publications in the literature addressing the risk for major birth defects following treatment or prophylaxis with one or both of these products, with the majority of the published data relating to oseltamivir exposure.
In a review by Tanaka et al. in 2009, 90 pregnancies treated therapeutically with oseltamivir in the first trimester were reported to two teratogen information services in Japan; one major birth defect (1.1%) was reported (CMAJ. 2009 Jul 7;181[1-2]:55-8). A year later, Greer et al. published a retrospective chart review at a Texas hospital between 2003 and 2008. During that period, 137 pregnancies that involved a pharmacy record of dispensing of oseltamivir were identified. Of these, 18 were dispensed in the first trimester, and none were linked to a major birth defect outcome (Obstet Gynecol. 2010 Apr;115[4]:711-6).
A 2011 record linkage study in Sweden identified 86 pregnant women for whom oseltamivir (n=81) or zanamivir had been prescribed. Of these, four were linked to a major birth defect in the infant; however, only one of the four prescriptions had been filled in the first trimester (Pharmacoepidemiol Drug Saf. 2011 Oct;20[10]:1030-4). In 2013, Saito et al. reported on a case series gathered from 157 obstetric facilities in Japan. Among 156 infants born to women exposed to oseltamivir in the first trimester, 2 (1.3%) were reported to have a major congenital anomaly; there were no congenital malformations reported in the 15 first-trimester exposures to zanamivir (Am J Obstet Gynecol. 2013 Aug;209[2[:130.e1-9).
In 2014, a teratogen information service in the United Kingdom reported on eight first-trimester exposures to oseltamivir and 37 to zanamivir, with no major birth defects noted in either group (BJOG. 2014 Jun;121[7]:901-6). Additionally, a French prescription database study identified 49 pregnancies thought to be exposed to oseltamivir in the first trimester with one reported congenital anomaly (BJOG. 2014 Jun;121[7]:895-900).
Finally, the manufacturer of oseltamivir published a summary of pregnancies from global pharmacovigilance data accumulated through spontaneous reports and other studies between 2000 and 2012 (Pharmacoepidemiol Drug Saf. 2014 Oct;23[10]:1035-42). Outcomes were available for 1,875 infants. Among these, 81 (4.3%) had major birth defects. However, following case review, the authors indicated that only 11 of the defects (occurring in 9 infants) were biologically plausible based on the timing of the exposure to oseltamivir.
Efficacy examined
With respect to efficacy, two small studies have addressed the pharmacokinetics of oseltamivir in pregnancy to determine if the recommended dosages for nonpregnant individuals are appropriate for pregnancy.
In the earlier of the two studies, Greer et al. looked at the pharmacokinetics of oseltamivir in 30 pregnant women, 10 in each of the three trimesters, who were taking 75 mg of the drug either once or twice daily. Maternal samples were drawn before and after the first dose of oseltamivir. They found little evidence of differences across the three trimesters and concluded that the parent drug values were in the pharmacologic range for clinical efficacy (Am J Obstet Gynecol. 2011 Jun;204[6 Suppl 1]:S89-93).
In contrast, Pillai et al. enrolled a small sample of women being treated with oseltamivir; they evaluated pharmacokinetics for the active metabolite of oseltamivir following 48 or more hours of treatment in 29 pregnant and 35 nonpregnant women (Br J Clin Pharmacol. 2015 Nov;80[5]:1042-50). Significantly lower levels of the active metabolite were noted in the pregnant women, compared with nonpregnant women. The authors suggested that the physiologic changes of pregnancy, correlated with increased renal clearance, produced an approximate 30% lower exposure to the drug in the pregnant state. While they were not able to relate this to maternal or infant outcomes, this finding suggested that further work is needed to determine if dosing recommendations should be adjusted in pregnancy.
The current recommendation is that pregnant women or women within 2 weeks post partum be given oseltamivir for treatment of suspected or confirmed influenza regardless of trimester of pregnancy. The limited safety data that are currently available have not suggested an increased risk for major birth defects following treatment with this product. However, the data are sparse for oseltamivir and even more so for zanamivir. Larger studies focused on these treatments are needed.
Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She reported having no financial disclosures relevant to this column, but has received research funding Roche-Genentech and GlaxoSmithKline unrelated to antiviral medications. Email her at [email protected].